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A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis (UC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
risankizumab IV
placebo for risankizumab
risankizumab SC
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring ABBV-066, BI 655066

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
  • Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
  • Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

  • Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Participant receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Participant with currently known complications of UC (e.g., megacolon).
  • No known active Coronavirus Disease - 2019 (COVID-19) infection.

Sites / Locations

  • Southern California Res. Ctr. /ID# 169660
  • Hoag Memorial Hosp Presbyterian /ID# 218348
  • UC San Diego Health System /ID# 160452
  • United Medical Doctors /ID# 158528
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931
  • UCSF Center for Colitis and Crohn's Disease /ID# 201210
  • Cedars-Sinai Medical Center-West Hollywood /ID# 163851
  • Peak Gastroenterology Associates, PC /ID# 165841
  • Rocky Mountain Pediatric Gastroenterology /ID# 207174
  • Medical Research Center of CT /ID# 160311
  • Yale Univ Digestive Diseases /ID# 213179
  • South Lake Pain Institute, Inc /ID# 162878
  • Ctr for Advanced Gastroenterol /ID# 202811
  • University of Miami /ID# 160471
  • Coral Research Clinic /ID# 158584
  • South Florida Research Ph I-IV, Inc. /ID# 161848
  • Gastroenterology Group Naples /ID# 165212
  • Advanced Research Institute, Inc /ID# 161938
  • Advent Health /ID# 160433
  • Endoscopic Research, Inc. /ID# 206711
  • Omega Research Group /ID# 203059
  • Lenus Research & Medical Group /ID# 169730
  • Clinical Research Trials of Florida, Inc. /ID# 201783
  • AdventHealth Tampa /ID# 170503
  • Gastroenterology Associates of Central Georgia, LLC /ID# 160523
  • Atlanta Gastroenterology Spec /ID# 161372
  • The University of Chicago Medical Center /ID# 160521
  • DM Clinical Research/Southwest /ID# 165012
  • Indiana University /ID# 167252
  • Univ Kansas Med Ctr /ID# 226602
  • Cotton-O'Neil Clinical Res Ctr /ID# 160412
  • Robley Rex VA Medical Center /ID# 218648
  • Houma Digestive Health Special /ID# 158317
  • Delricht Research /ID# 206815
  • Nola Research Works, LLC /ID# 161368
  • Louisana Research Center, LLC /ID# 201204
  • Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524
  • Clin Res Inst of Michigan, LLC /ID# 160327
  • Mayo Clinic - Rochester /ID# 200458
  • Quality Clinical Research Inc. /ID# 167313
  • Weill Cornell Medicine /ID# 165887
  • Columbia Univ Medical Center /ID# 161934
  • Lenox Hill Hospital /ID# 168470
  • Manhattan Clinical Research, LLC /ID# 211805
  • DiGiovanna Institute for Medical Education & Research /ID# 171129
  • University of Rochester Medical Center /ID# 161664
  • Atrium Health Carolinas Medical Center /ID# 158512
  • Carolina Research /ID# 201090
  • Plains Clinical Research Center, LLC /ID# 169732
  • Cleveland Clinic Main Campus /ID# 209232
  • The Ohio State University /ID# 164714
  • Optimed Research, Ltd. /ID# 167113
  • Great Lakes Gastroenterology Research, LLC /ID# 201777
  • ProMedica Physicians Digestive Healthcare /ID# 215623
  • Digestive Disease Specialists /ID# 170779
  • Adult Gastroenterology Associates - Gen 1 Research /ID# 208867
  • Penn State Milton S. Hershey Medical Center /ID# 223563
  • University of Pennsylvania /ID# 166266
  • Digestive Disease Associates, LTD /ID# 232407
  • Gastroenterology Associates, P.A. of Greenville /ID# 160472
  • Gastro One /ID# 160418
  • East Tennessee Research Institute /ID# 168747
  • Vanderbilt University Medical Center /ID# 160580
  • Inquest Clinical Research /ID# 165685
  • Texas Digestive Disease Consultants /ID# 209950
  • Texas Digestive Disease Consultants /ID# 209798
  • DHAT Research Institute /ID# 158226
  • Vilo Research Group Inc /ID# 207656
  • CliniCore International, LLC /ID# 158218
  • Baylor College of Medicine - Baylor Medical Center /ID# 158221
  • Precision Research Institute, LLC /ID# 201351
  • Centex Studies, Inc. - Houston /ID# 201222
  • Caprock Gastro Research, LLC /ID# 215432
  • Clinical Associates in Research Therapeutics of America, LLC /ID# 161376
  • Southern Star Research Institute, LLC /ID# 168776
  • Baylor Scott & White Center for Diagnostic Medicine /ID# 204130
  • Tyler Research Institute, LLC /ID# 166800
  • Gastro Health & Nutrition - Victoria /ID# 164321
  • Advanced Research Institute /ID# 160480
  • Gastroenterology Consultants of Southwest Virginia /ID# 218143
  • Virginia Mason Medical Center /ID# 160466
  • Gedyt /ID# 243423
  • Cemic /Id# 167782
  • Hospital Provincial del Centenario /ID# 170898
  • Sanatorio 9 de Julio /ID# 167780
  • Hospital Privado Univesitario /ID# 167779
  • Duplicate_Universitaetsklinikum St.Poelten /ID# 169048
  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320
  • Medizinische Universitaet Graz /ID# 169053
  • Medizinische Universitaet Wien /ID# 169050
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685
  • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252
  • UCL Saint-Luc /ID# 200039
  • CHU UCL Namur - site Godinne /ID# 200254
  • Universitair Ziekenhuis Leuven /ID# 170812
  • AZ-Delta /ID# 200040
  • Imelda Ziekenhuis /ID# 211100
  • CHU de Liege /ID# 200253
  • Groupe Sante CHC - Clinique du MontLegia /ID# 200250
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679
  • Hospital Nossa Senhora das Graças /ID# 157671
  • Hospital de Clinicas de Porto Alegre /ID# 157662
  • Upeclin Fmb - Unesp /Id# 157690
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660
  • Faculdade de Medicina do ABC /ID# 163995
  • Kaiser Clinica e Hospital Dia /ID# 157680
  • UMHAT Kaspela EOOD /ID# 200797
  • MHAT Hadzhi Dimitar /ID# 207945
  • Second Multiprofile Hospital f /ID# 200799
  • UMHAT Sveti Ivan Rilski /ID# 210797
  • UMHAT Tsaritsa Joanna - ISUL /ID# 209977
  • University of Calgary /ID# 169111
  • Allen Whey Khye Lim Professional Corporation /ID# 169767
  • Covenant Health /ID# 169114
  • Fraser Clinical Trials Inc /ID# 169102
  • Percuro Clinical Research, Ltd /ID# 169109
  • London Health Sciences Center /ID# 169103
  • Scott Shulman Medicine Professional Corporation /ID# 169113
  • Toronto Digestive Disease Asso /ID# 169106
  • Hotel Dieu de Levis /ID# 214378
  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108
  • Royal Victoria Hospital / McGill University Health Centre /ID# 169104
  • Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151
  • Complejo Asistencial Dr. Sotero del Rio /ID# 169385
  • Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125
  • Hospital Guillermo Grant Benavente de Concepción /ID# 210761
  • Hospital Las Higueras /ID# 167093
  • The First Affiliated Hospital of Anhui Medical University /ID# 211228
  • Beijing Friendship Hospital /ID# 211066
  • The Sixth Affiliated Hosp Sun /ID# 211231
  • The Second Hospital of Hebei Medical University /ID# 213018
  • Tongji Hospital Tongji Medical College of HUST /ID# 211072
  • Renmin Hospital of Wuhan University /ID# 212868
  • Huai'an First People's Hospital /ID# 239196
  • Nanjing Drum Tower Hospital /ID# 227439
  • Jiangsu Province Hospital /ID# 211232
  • Wuxi People's Hospital /ID# 218798
  • The First Affiliated Hospital of Nanchang University /ID# 212183
  • The First Hospital of Jilin University /ID# 212278
  • General Hospital of Ningxia Medical University /ID# 213911
  • Xijing Hospital /ID# 211639
  • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504
  • Shanghai East Hospital /ID# 218791
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962
  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233
  • Shanghai General Hospital /ID# 226190
  • West China Hospital, Sichuan University /ID# 211276
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025
  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064
  • The Second Xiangya Hospital of Central South University /ID# 211198
  • Shengjing Hospital of China Medical University /ID# 211646
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071
  • Oncomédica SAS /ID# 206937
  • Hospital Universitario San Vic /ID# 171490
  • Clinical Hospital Dubrava /ID# 157475
  • Klinicki bolnicki centar Zagreb /ID# 157471
  • Klinicki bolnicki centar Zagreb /ID# 201917
  • Klinicki bolnicki centar Osijek /ID# 157472
  • Klinicki bolnicki centar Split /ID# 157473
  • Fakultni nemocnice u sv. Anny v Brne /ID# 239157
  • Nemocnice Ceske Budejovice a.s. /ID# 225226
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 163395
  • Fakultni nemocnice Ostrava /ID# 225567
  • Bispebjerg and Frederiksberg Hospital /ID# 208945
  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266
  • Sjællands Universitetshospital /ID# 200033
  • Odense University Hospital /ID# 205602
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793
  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794
  • Air Force Specialized Hospital /ID# 170986
  • National Liver Institute /ID# 171040
  • Chu de Nice-Hopital L'Archet Ii /Id# 171577
  • APHM - Hopital Nord /ID# 225825
  • CHU Bordeaux - Hopital Haut Leveque /ID# 171579
  • CHU Montpellier - Hôpital Saint Eloi /ID# 223779
  • Hopital Beaujon /ID# 200092
  • Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249860
  • CHU de SAINT ETIENNE - Hopital Nord /ID# 171580
  • CHRU Nancy - Hopitaux de Brabois /ID# 200095
  • CHU Amiens-Picardie Site Sud /ID# 171576
  • Clinique Jules Verne /ID# 240976
  • Universitaetsklinikum Freiburg /ID# 162034
  • Praxis fuer Gastroenterologie /ID# 166152
  • Universitatsklinikum Mannheim /ID# 162035
  • Universitaetsklinikum Ulm /ID# 164992
  • Universitaetsklinikum Erlangen /ID# 159354
  • Praxiszentrum fuer Gastroenterologie /ID# 219069
  • Universitaetsklinikum Koeln /ID# 164991
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360
  • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145
  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361
  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510
  • DRK Kliniken Berlin Westend /ID# 166153
  • Stadtisches Klinikum Braunschweig /ID# 163687
  • Agaplesion Markus Krankenhaus /ID# 159356
  • Gastroenterologie Opernstrasse /ID# 163683
  • EUGASTRO GmbH /ID# 219070
  • Klinikum Lueneburg /ID# 163685
  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033
  • LMU Klinikum Campus Grosshadern /ID# 210481
  • Universitaetsklinikum Regensburg /ID# 163686
  • General Hospital of Athens Ippokratio /ID# 229189
  • General Hospital of Athens Laiko /ID# 206440
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915
  • Tzaneio general hospital of Piraeus /ID# 206439
  • University General Hospital of Heraklion PA.G.N.I /ID# 165216
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480
  • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218
  • Theageneio Anticancer Hospital /ID# 165217
  • Soroka University Medical Center /ID# 171100
  • The Chaim Sheba Medical Center /ID# 211278
  • Hadassah Medical Center-Hebrew University /ID# 171099
  • Rambam Health Care Campus /ID# 171103
  • Shaare Zedek Medical Center /ID# 163544
  • Rabin Medical Center /ID# 167403
  • University of Catanzaro /ID# 200125
  • Ospedale Sant Orsola Malpighi /ID# 155611
  • Ospedale Policlinico San Martino /ID# 164031
  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163992
  • Azienda Ospedaliera San Camillo Forlanini /ID# 155612
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226
  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449
  • Istituto Clinico Humanitas /ID# 155610
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158018
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041
  • A.O. Per L'Emergenza Cannizzaro /ID# 164036
  • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607
  • ASST Grande Ospedale Metropolitano Niguarda /ID# 170947
  • Azienda Ospedaliero-Universitaria di Modena /ID# 201819
  • UOC Medicina Interna e Gastroe /ID# 155608
  • Aichi Medical University Hospital /ID# 164332
  • Nagoya City University Hospital /ID# 164331
  • Daido Clinic /ID# 211479
  • Nagoya University Hospital /ID# 164271
  • Fujita Health University Hospital /ID# 164261
  • National Hospital Organization Hirosaki General Medical Center /ID# 164252
  • Tokatsu Tsujinaka Hospital /ID# 164438
  • Chiba University Hospital /ID# 209632
  • Tsujinaka Hospital Kashiwanoha /ID# 208964
  • Toho University Sakura Medical Center /ID# 164254
  • Fukuoka University Chikushi Hospital /ID# 209055
  • Saiseikai Fukuoka Genaral Hospital /ID# 225639
  • Fukuoka University Hospital /ID# 226189
  • Kurume University Hospital /ID# 164427
  • Gifu University Hospital /ID# 208081
  • Ogaki Municipal Hospital /ID# 226010
  • National Hospital Organization Takasaki General Medical Center /ID# 164437
  • NHO Fukuyama Medical Center /ID# 164439
  • Hiroshima University Hospital /ID# 164426
  • Asahikawa Medical University Hospital /ID# 164433
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251
  • Sapporo Medical University Hospital /ID# 164432
  • Sapporo IBD Clinic /ID# 225923
  • Sapporo Higashi Tokushukai Hospital /ID# 208488
  • Aoyama Clinic /ID# 164425
  • Hyogo Medical University Hospital /ID# 164424
  • Kanazawa University Hospital /ID# 169224
  • Sameshima Hospital /ID# 211181
  • Tokai University Hospital /ID# 209204
  • Gokeikai Ofuna Chuo Hospital /ID# 169300
  • St. Marianna University Hospital /ID# 226728
  • Kitasato University Hospital /ID# 169226
  • Colo-proctology Center Matsushima Clinic /ID# 225914
  • Showa University Fujigaoka Hospital /ID# 209555
  • Mie University Hospital /ID# 203633
  • Yokkaichi Hazu Medical Center /ID# 164441
  • Tohoku University Hospital /ID# 164430
  • Nagasaki University Hospital /ID# 202674
  • Nara Medical University Hospital /ID# 169225
  • Kinshukai Infusion Clinic /ID# 226747
  • Osaka Medical and Pharmaceutical University Hospital /ID# 226035
  • Saga University Hospital /ID# 209396
  • Tokitokai Tokito clinic /ID# 164253
  • Shiga University of Medical Science Hospital /ID# 164440
  • Hamamatsu University Hospital /ID# 226727
  • Matsuda Hospital /ID# 226616
  • NHO Shizuoka Medical Center /ID# 164435
  • Tokyo Medical And Dental University Hospital /ID# 164258
  • St.Luke's International Hospital /ID# 225822
  • Tokai University Hachioji Hospital /ID# 226899
  • Teikyo University Hospital /ID# 225588
  • The Jikei University Hospital /ID# 164434
  • Kitasato University Kitasato Institute Hospital /ID# 164256
  • Kyorin University Hospital /ID# 164259
  • NTT Medical Center Tokyo /ID# 225587
  • Keio University Hospital /ID# 203629
  • Japanese Red Cross Wakayama Medical Center /ID# 171195
  • Wakayama Medical University Hospital /ID# 169487
  • Yamagata University Hospital /ID# 171474
  • Tokuyama Central Hospital /ID# 226011
  • Hanyang University Gurihospital /ID# 158702
  • CHA University Bundang Medical Center /ID# 158710
  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706
  • Kangbuk Samsung Hospital /ID# 158707
  • Yonsei University Health System Severance Hospital /ID# 158701
  • Inje University Haeundae Hospital /ID# 203028
  • Dong-A University Hospital /ID# 158705
  • Pusan National University Hospital /ID# 158711
  • Yeungnam University Medical Center /ID# 158703
  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378
  • Samsung Medical Center /ID# 158704
  • VCA Polyclinic Aura /ID# 163802
  • Pauls Stradins Clinical University Hospital /ID# 163803
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714
  • Vilnius University Hospital Santaros Klinikos /ID# 170614
  • Universiti Sains Malaysia /ID# 221971
  • JM Research SC /ID# 203593
  • Unidad de Atencion Medica e Investigacion en Salud /ID# 203595
  • Health Pharma Professional Research S.A de C.V /ID# 203597
  • Academisch Medisch Centrum /ID# 157959
  • Elisabeth Tweesteden Ziekenhuis /ID# 163767
  • Tauranga Hospital /ID# 212792
  • Christchurch Hospital /ID# 205342
  • Waikato Hospital /ID# 212789
  • Wellington Regional Hospital /ID# 205343
  • Hutt Hospital /ID# 212786
  • Dunedin Hospital /ID# 212790
  • Vistamed /ID# 210105
  • Vitamed Gałaj i Cichomski Sp.j. /ID# 213283
  • Gastromed Sp. z o.o /ID# 230978
  • Centrum Medyczne Plejady /ID# 170633
  • WIP Warsaw IBD Point Profesor Kierkus /ID# 216102
  • Centrum Zdrowia MDM /ID# 170597
  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170601
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170600
  • NZOZ Vivamed Jadwiga Miecz /ID# 216307
  • Endoskopia Sp. z o.o. /ID# 170598
  • NZOZ All-Medicus /ID# 170596
  • H-T. Centrum Medyczne - Endoterapia /ID# 230979
  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580
  • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551
  • Centro Hospitalar de Entre Douro e Vouga /ID# 166052
  • Hospital Garcia de Orta, EPE /ID# 165583
  • Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054
  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581
  • Centro Hosp de Tondela-Viseu /ID# 166053
  • Ponce Medical School Foundation /ID# 221244
  • San Jorge Children Hospital /ID# 166954
  • VA Caribbean Healthcare System /ID# 221245
  • Clinica GASTRO MED SRL /ID# 224169
  • Sana Monitoring /Id# 224166
  • Fundeni Clinical Institute /ID# 171264
  • Fundeni Clinical Institute /ID# 224168
  • Duplicate_Centrul Medical Tuculanu SRL /ID# 171268
  • Cabinet Particular Policlinic Algomed /ID# 171266
  • Interdisctrict Multidisciplinary Hospital /ID# 203335
  • GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973
  • Immanuel Kant Baltic Federal University /ID# 204888
  • Kuzbass Regional Clinical Hospital /ID# 165750
  • Uninova Medical Center /ID# 229216
  • Arsvita Clinic /ID# 208946
  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457
  • City Clinical Hospital #40 /ID# 203370
  • Regional Clinical Hospital #1 /ID# 165754
  • Clinic of New Technologies of Medicine /ID# 203369
  • First Moscow State Medical University n.a I.M. Sechenov /ID# 204978
  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512
  • Central Clinical Hospital RZHD Medicine /ID# 204917
  • Novosibirski Gastrocenter /ID# 229855
  • Euromedservice /ID# 204892
  • International Medical Center SOGAZ /ID# 206727
  • Ulyanovsk Regional Clinical Hospital /ID# 203368
  • Clinical Hosp Center Zvezdara /ID# 200151
  • University Clinical Center Serbia /ID# 200152
  • Clin Hosp Ctr Bezanijska Kosa /ID# 202059
  • Clinical Center Vojvodina /ID# 156910
  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926
  • General Hospital Leskovac /ID# 207226
  • KL Ling Gastroenterology and Liver Clinic /ID# 205738
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347
  • KM Management, spol. s.r.o. /ID# 206602
  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099
  • GASTRO I., s.r.o. /ID# 164346
  • Univ Medical Ctr Ljubljana /ID# 210627
  • Farmovs (Pty) Ltd /Id# 207537
  • Clinresco Centers /ID# 239824
  • Spoke Research Inc /ID# 229905
  • Allergy & Immunology (AIU) /ID# 171441
  • Dr JP Wright /ID# 171138
  • Private Practice Dr MN Rajabally /ID# 171137
  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440
  • Hospital de Cabuenes /ID# 170748
  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461
  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443
  • Hospital Alvaro Cunqueiro CHUVI /ID# 167360
  • Hospital Clinic de Barcelona /ID# 159439
  • Hospital Universitario Reina Sofia /ID# 167058
  • Hospital Universitario La Paz /ID# 159459
  • Complejo Hospitalario Universitario de Pontevedra /ID# 216182
  • Hospital Universitario de Salamanca /ID# 159446
  • Hospital Universitario Virgen Macarena /ID# 159968
  • Hospital Universitario Miguel Servet /ID# 159445
  • Alingsas lasarett /ID# 202074
  • Sahlgrenska University Hospital Molndal /ID# 202843
  • Danderyds sjukhus AB /ID# 202035
  • Universitatsspital Zurich /ID# 202910
  • Inselspital, Universitätsspital Bern /ID# 202911
  • Chung Shan Medical University Hospital /ID# 163651
  • China Medical University Hospital /ID# 160189
  • Taichung Veterans General Hospital /ID# 163649
  • National Taiwan University Hospital /ID# 162187
  • Taipei Veterans General Hosp /ID# 163650
  • Linkou Chang Gung Memorial Hospital /ID# 222877
  • Acibadem Kozyatagi Hospital /ID# 213276
  • Erciyes University Medical Fac /ID# 171291
  • Ankara Univ Medical Faculty /ID# 167210
  • Inonu Universitesi Turgut Ozal /ID# 203981
  • Uludag University Medical Faculty /ID# 204182
  • Fırat University Medical Facul /ID# 171292
  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293
  • Sisli Etfal Train & Res Hosp /ID# 171409
  • CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367
  • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350
  • Kyiv Municipal Clinical Hospital #18 /ID# 224348
  • Medical Center "OK!Clinic+" /ID# 205482
  • CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343
  • Royal Devon University Healthcare NHS Foundation Trust /ID# 157587
  • University Hospital Southampton NHS Foundation Trust /ID# 210813
  • Barts Health NHS Trust /ID# 157590
  • Barnsley Hospital NHS Foundation Trust /ID# 202770
  • Cambridge University Hospitals NHS Foundation Trust /ID# 158040
  • NHS Lothian /ID# 208802
  • Liverpool University Hospitals NHS Foundation Trust /ID# 203858
  • King's College Hospital NHS Foundation Trust /ID# 158766
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041
  • St George's University Hospitals NHS Foundation Trust /ID# 208378

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Substudy 1, Induction 1: Double-blind Risankizumab Dose 1

Substudy 1, Induction 1: Double-blind Risankizumab Dose 2

Substudy 1, Induction 1: Double-blind Risankizumab Dose 3

Substudy 1, Induction 1: Double-blind Placebo

Substudy 1, Induction 1: Open-label Risankizumab Dose 1

Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)

Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)

Substudy 1, Induction 2: Double-blind Risankizumab Dose 2

Substudy 1, Induction 2: Double-blind Risankizumab Dose 3

Substudy 2, Induction 1: Double-blind Risankizumab Dose 1

Substudy 2, Induction 1: Double-blind Placebo

Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)

Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)

Substudy 2, Induction 2: Double-blind Risankizumab Dose 2

Substudy 2, Induction 2: Double-blind Risankizumab Dose 3

Arm Description

Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.

Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Participants receive risankizumab dose 1 administered by intravenous (IV) infusion.

Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.

Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.

Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.

Outcomes

Primary Outcome Measures

Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Clinical remission per adapted Mayo Score.

Secondary Outcome Measures

Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement per endoscopy subscore.
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline
Clinical remission per Full Mayo Score.
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Clinical response per adapted Mayo Score.
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score
Clinical response per Partial Adapted Mayo Score (without endoscopy).
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission per endoscopy subscore.
Sub-Study 1: Percentage of Participants with Hospitalization
Participants with an event that results in admission to the hospital.
Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)
Mucosal healing defined as endoscopic and histologic remission.
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)
The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Sub-Study 1: Change in Short Form-36 (SF-36)
The SF-36 is an indicator of overall health status.
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-related Surgeries
Participants who underwent surgery related to UC.
Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Clinical response per adapted Mayo Score.
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement per endoscopy subscore.
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)
Endoscopic subscore of 0 or 1 without evidence of friability and Geboes score ≤ 3.1) at Week 12
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission per endoscopy subscore.
Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score at Week 4
Clinical response per Partial Adapted Mayo Score (without endoscopy).
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency
Percentage of participants who reported no bowel urgency.
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain
Percentage of participants who reported no abdominal pain.
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12
Mucosal healing defined as endoscopic and histologic remission.
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Sub-Study 2: Occurrence of UC-related Hospitalizations
Participants with an UC-related event that results in admission to the hospital.
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
Percentage of participants who reported no nocturnal bowel movements.
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
Percentage of participants who reported no tenesmus.
Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week
Change in number of fecal incontinence episodes per week.
Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
Change in number of days per week with sleep interrupted due to UC symptoms.

Full Information

First Posted
January 8, 2018
Last Updated
July 25, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03398148
Brief Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
Keywords
ABBV-066, BI 655066

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Substudy 1, Induction 1: Double-blind Risankizumab Dose 1
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Arm Title
Substudy 1, Induction 1: Double-blind Risankizumab Dose 2
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Arm Title
Substudy 1, Induction 1: Double-blind Risankizumab Dose 3
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.
Arm Title
Substudy 1, Induction 1: Double-blind Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Arm Title
Substudy 1, Induction 1: Open-label Risankizumab Dose 1
Arm Type
Experimental
Arm Description
Participants receive risankizumab dose 1 administered by intravenous (IV) infusion.
Arm Title
Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)
Arm Type
Experimental
Arm Description
Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Arm Title
Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)
Arm Type
Experimental
Arm Description
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Arm Title
Substudy 1, Induction 2: Double-blind Risankizumab Dose 2
Arm Type
Experimental
Arm Description
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
Arm Title
Substudy 1, Induction 2: Double-blind Risankizumab Dose 3
Arm Type
Experimental
Arm Description
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
Arm Title
Substudy 2, Induction 1: Double-blind Risankizumab Dose 1
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Arm Title
Substudy 2, Induction 1: Double-blind Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Arm Title
Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)
Arm Type
Experimental
Arm Description
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Arm Title
Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)
Arm Type
Experimental
Arm Description
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Arm Title
Substudy 2, Induction 2: Double-blind Risankizumab Dose 2
Arm Type
Experimental
Arm Description
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
Arm Title
Substudy 2, Induction 2: Double-blind Risankizumab Dose 3
Arm Type
Experimental
Arm Description
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
Intervention Type
Drug
Intervention Name(s)
risankizumab IV
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
risankizumab intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
placebo for risankizumab
Intervention Description
placebo for risankizumab
Intervention Type
Drug
Intervention Name(s)
risankizumab SC
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
risankizumab subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Description
Clinical remission per adapted Mayo Score.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Description
Endoscopic improvement per endoscopy subscore.
Time Frame
Week 12
Title
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline
Description
Clinical remission per Full Mayo Score.
Time Frame
Week 12
Title
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Description
Clinical response per adapted Mayo Score.
Time Frame
Week 12
Title
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score
Description
Clinical response per Partial Adapted Mayo Score (without endoscopy).
Time Frame
Week 4
Title
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Description
Endoscopic remission per endoscopy subscore.
Time Frame
Week 12
Title
Sub-Study 1: Percentage of Participants with Hospitalization
Description
Participants with an event that results in admission to the hospital.
Time Frame
Through Week 12
Title
Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)
Description
Mucosal healing defined as endoscopic and histologic remission.
Time Frame
Week 12
Title
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)
Description
The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
Time Frame
Baseline Through Week 12
Title
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Description
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Time Frame
Baseline Through Week 12
Title
Sub-Study 1: Change in Short Form-36 (SF-36)
Description
The SF-36 is an indicator of overall health status.
Time Frame
Baseline Through Week 12
Title
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Time Frame
Baseline Through Week 12
Title
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-related Surgeries
Description
Participants who underwent surgery related to UC.
Time Frame
Through Week 12
Title
Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Description
Clinical response per adapted Mayo Score.
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement
Description
Endoscopic improvement per endoscopy subscore.
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)
Description
Endoscopic subscore of 0 or 1 without evidence of friability and Geboes score ≤ 3.1) at Week 12
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
Description
Endoscopic remission per endoscopy subscore.
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score at Week 4
Description
Clinical response per Partial Adapted Mayo Score (without endoscopy).
Time Frame
Week 4
Title
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency
Description
Percentage of participants who reported no bowel urgency.
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain
Description
Percentage of participants who reported no abdominal pain.
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12
Description
Mucosal healing defined as endoscopic and histologic remission.
Time Frame
Week 12
Title
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Time Frame
Baseline to Week 12
Title
Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
Description
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Time Frame
Baseline to Week 12
Title
Sub-Study 2: Occurrence of UC-related Hospitalizations
Description
Participants with an UC-related event that results in admission to the hospital.
Time Frame
Baseline Through Week 12
Title
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
Description
Percentage of participants who reported no nocturnal bowel movements.
Time Frame
Week 12
Title
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
Description
Percentage of participants who reported no tenesmus.
Time Frame
Week 12
Title
Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week
Description
Change in number of fecal incontinence episodes per week.
Time Frame
Baseline to Week 12
Title
Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
Description
Change in number of days per week with sleep interrupted due to UC symptoms.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit. Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline. Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore. Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control. Exclusion Criteria: Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis. Participant receiving prohibited medications and treatment. Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. Participant with currently known complications of UC (e.g., megacolon). No known active Coronavirus Disease - 2019 (COVID-19) infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Res. Ctr. /ID# 169660
City
Coronado
State/Province
California
ZIP/Postal Code
92118-1408
Country
United States
Facility Name
Hoag Memorial Hosp Presbyterian /ID# 218348
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
UC San Diego Health System /ID# 160452
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
United Medical Doctors /ID# 158528
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067-2001
Country
United States
Facility Name
UCSF Center for Colitis and Crohn's Disease /ID# 201210
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-3011
Country
United States
Facility Name
Cedars-Sinai Medical Center-West Hollywood /ID# 163851
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Peak Gastroenterology Associates, PC /ID# 165841
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Pediatric Gastroenterology /ID# 207174
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124-6798
Country
United States
Facility Name
Medical Research Center of CT /ID# 160311
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Yale Univ Digestive Diseases /ID# 213179
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
South Lake Pain Institute, Inc /ID# 162878
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Ctr for Advanced Gastroenterol /ID# 202811
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Facility Name
University of Miami /ID# 160471
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Coral Research Clinic /ID# 158584
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-4643
Country
United States
Facility Name
South Florida Research Ph I-IV, Inc. /ID# 161848
City
Miami
State/Province
Florida
ZIP/Postal Code
33193
Country
United States
Facility Name
Gastroenterology Group Naples /ID# 165212
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 161938
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Advent Health /ID# 160433
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 206711
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Omega Research Group /ID# 203059
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Lenus Research & Medical Group /ID# 169730
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 201783
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
AdventHealth Tampa /ID# 170503
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4680
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 160523
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Atlanta Gastroenterology Spec /ID# 161372
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 160521
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
DM Clinical Research/Southwest /ID# 165012
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University /ID# 167252
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ Kansas Med Ctr /ID# 226602
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cotton-O'Neil Clinical Res Ctr /ID# 160412
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Robley Rex VA Medical Center /ID# 218648
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Houma Digestive Health Special /ID# 158317
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Delricht Research /ID# 206815
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Nola Research Works, LLC /ID# 161368
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 201204
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clin Res Inst of Michigan, LLC /ID# 160327
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 200458
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Quality Clinical Research Inc. /ID# 167313
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-3723
Country
United States
Facility Name
Weill Cornell Medicine /ID# 165887
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 161934
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Lenox Hill Hospital /ID# 168470
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Manhattan Clinical Research, LLC /ID# 211805
City
New York
State/Province
New York
ZIP/Postal Code
10279
Country
United States
Facility Name
DiGiovanna Institute for Medical Education & Research /ID# 171129
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
University of Rochester Medical Center /ID# 161664
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 158512
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Carolina Research /ID# 201090
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 169732
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 209232
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 164714
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Optimed Research, Ltd. /ID# 167113
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC /ID# 201777
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6211
Country
United States
Facility Name
ProMedica Physicians Digestive Healthcare /ID# 215623
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560-2767
Country
United States
Facility Name
Digestive Disease Specialists /ID# 170779
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Adult Gastroenterology Associates - Gen 1 Research /ID# 208867
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-7823
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center /ID# 223563
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
University of Pennsylvania /ID# 166266
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Digestive Disease Associates, LTD /ID# 232407
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610-2002
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 160472
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Gastro One /ID# 160418
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
East Tennessee Research Institute /ID# 168747
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 160580
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Inquest Clinical Research /ID# 165685
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209950
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-5028
Country
United States
Facility Name
Texas Digestive Disease Consultants /ID# 209798
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
DHAT Research Institute /ID# 158226
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Facility Name
Vilo Research Group Inc /ID# 207656
City
Houston
State/Province
Texas
ZIP/Postal Code
77017-2337
Country
United States
Facility Name
CliniCore International, LLC /ID# 158218
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-6812
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 158221
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Precision Research Institute, LLC /ID# 201351
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 201222
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Caprock Gastro Research, LLC /ID# 215432
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424-3017
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 161376
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 168776
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Baylor Scott & White Center for Diagnostic Medicine /ID# 204130
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 166800
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
Gastro Health & Nutrition - Victoria /ID# 164321
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Advanced Research Institute /ID# 160480
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Gastroenterology Consultants of Southwest Virginia /ID# 218143
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014-1372
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 160466
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Gedyt /ID# 243423
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1115
Country
Argentina
Facility Name
Cemic /Id# 167782
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital Provincial del Centenario /ID# 170898
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio 9 de Julio /ID# 167780
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 167779
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Duplicate_Universitaetsklinikum St.Poelten /ID# 169048
City
St. Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medizinische Universitaet Graz /ID# 169053
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8010
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 169050
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL Saint-Luc /ID# 200039
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU UCL Namur - site Godinne /ID# 200254
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 170812
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ-Delta /ID# 200040
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Imelda Ziekenhuis /ID# 211100
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
CHU de Liege /ID# 200253
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 200250
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Hospital Nossa Senhora das Graças /ID# 157671
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 157662
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Upeclin Fmb - Unesp /Id# 157690
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Faculdade de Medicina do ABC /ID# 163995
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Kaiser Clinica e Hospital Dia /ID# 157680
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015-110
Country
Brazil
Facility Name
UMHAT Kaspela EOOD /ID# 200797
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
MHAT Hadzhi Dimitar /ID# 207945
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Second Multiprofile Hospital f /ID# 200799
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 210797
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna - ISUL /ID# 209977
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
University of Calgary /ID# 169111
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 169767
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
Covenant Health /ID# 169114
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Fraser Clinical Trials Inc /ID# 169102
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
Percuro Clinical Research, Ltd /ID# 169109
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
London Health Sciences Center /ID# 169103
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Scott Shulman Medicine Professional Corporation /ID# 169113
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 169106
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Hotel Dieu de Levis /ID# 214378
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 169104
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151
City
Victoria
State/Province
Araucania
ZIP/Postal Code
4720843
Country
Chile
Facility Name
Complejo Asistencial Dr. Sotero del Rio /ID# 169385
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
8350488
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 210761
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Hospital Las Higueras /ID# 167093
City
Talcahuano
ZIP/Postal Code
1740000
Country
Chile
Facility Name
The First Affiliated Hospital of Anhui Medical University /ID# 211228
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Beijing Friendship Hospital /ID# 211066
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The Sixth Affiliated Hosp Sun /ID# 211231
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
The Second Hospital of Hebei Medical University /ID# 213018
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 211072
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University /ID# 212868
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Huai'an First People's Hospital /ID# 239196
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223399
Country
China
Facility Name
Nanjing Drum Tower Hospital /ID# 227439
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Province Hospital /ID# 211232
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Wuxi People's Hospital /ID# 218798
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 212183
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University /ID# 212278
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
General Hospital of Ningxia Medical University /ID# 213911
City
Yinchuan City
State/Province
Ningxia
ZIP/Postal Code
750000
Country
China
Facility Name
Xijing Hospital /ID# 211639
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Shanghai East Hospital /ID# 218791
City
Pudong New District
State/Province
Shanghai
ZIP/Postal Code
200136
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Shanghai General Hospital /ID# 226190
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201600
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 211276
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
The Second Xiangya Hospital of Central South University /ID# 211198
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Shengjing Hospital of China Medical University /ID# 211646
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071
City
Wuhan
ZIP/Postal Code
420022
Country
China
Facility Name
Oncomédica SAS /ID# 206937
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230003
Country
Colombia
Facility Name
Hospital Universitario San Vic /ID# 171490
City
Medellin
ZIP/Postal Code
50010
Country
Colombia
Facility Name
Clinical Hospital Dubrava /ID# 157475
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 157471
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 201917
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Osijek /ID# 157472
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 157473
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Fakultni nemocnice u sv. Anny v Brne /ID# 239157
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice a.s. /ID# 225226
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 163395
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava /ID# 225567
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Bispebjerg and Frederiksberg Hospital /ID# 208945
City
Copenhagen NV
State/Province
Hovedstaden
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266
City
Hvidovre
State/Province
Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Sjællands Universitetshospital /ID# 200033
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Odense University Hospital /ID# 205602
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Air Force Specialized Hospital /ID# 170986
City
Cairo
Country
Egypt
Facility Name
National Liver Institute /ID# 171040
City
Menoufiya
ZIP/Postal Code
35111
Country
Egypt
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 171577
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
APHM - Hopital Nord /ID# 225825
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13015
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 171579
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 223779
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Beaujon /ID# 200092
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249860
City
Neuilly Sur Seine
State/Province
Ile-de-France
ZIP/Postal Code
92200
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 171580
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU Nancy - Hopitaux de Brabois /ID# 200095
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Amiens-Picardie Site Sud /ID# 171576
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
Clinique Jules Verne /ID# 240976
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
Universitaetsklinikum Freiburg /ID# 162034
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Praxis fuer Gastroenterologie /ID# 166152
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
Universitatsklinikum Mannheim /ID# 162035
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 164992
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Erlangen /ID# 159354
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Praxiszentrum fuer Gastroenterologie /ID# 219069
City
Grevenbroich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41515
Country
Germany
Facility Name
Universitaetsklinikum Koeln /ID# 164991
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
DRK Kliniken Berlin Westend /ID# 166153
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Stadtisches Klinikum Braunschweig /ID# 163687
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 159356
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Gastroenterologie Opernstrasse /ID# 163683
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
EUGASTRO GmbH /ID# 219070
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Lueneburg /ID# 163685
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
LMU Klinikum Campus Grosshadern /ID# 210481
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitaetsklinikum Regensburg /ID# 163686
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
General Hospital of Athens Ippokratio /ID# 229189
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Athens Laiko /ID# 206440
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Tzaneio general hospital of Piraeus /ID# 206439
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18536
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 165216
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218
City
Pireaus
ZIP/Postal Code
18454
Country
Greece
Facility Name
Theageneio Anticancer Hospital /ID# 165217
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Facility Name
Soroka University Medical Center /ID# 171100
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
The Chaim Sheba Medical Center /ID# 211278
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 171099
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 171103
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 163544
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rabin Medical Center /ID# 167403
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
University of Catanzaro /ID# 200125
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale Sant Orsola Malpighi /ID# 155611
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Policlinico San Martino /ID# 164031
City
Genoa
State/Province
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163992
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 155612
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 155610
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158018
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
A.O. Per L'Emergenza Cannizzaro /ID# 164036
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda /ID# 170947
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 201819
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
UOC Medicina Interna e Gastroe /ID# 155608
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Aichi Medical University Hospital /ID# 164332
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 164331
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Daido Clinic /ID# 211479
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Nagoya University Hospital /ID# 164271
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Fujita Health University Hospital /ID# 164261
City
Toyoake-shi
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Hospital Organization Hirosaki General Medical Center /ID# 164252
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Tokatsu Tsujinaka Hospital /ID# 164438
City
Abiko-shi
State/Province
Chiba
ZIP/Postal Code
270-1168
Country
Japan
Facility Name
Chiba University Hospital /ID# 209632
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha /ID# 208964
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 164254
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital /ID# 209055
City
Chikushino-shi
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Saiseikai Fukuoka Genaral Hospital /ID# 225639
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Fukuoka University Hospital /ID# 226189
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kurume University Hospital /ID# 164427
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Gifu University Hospital /ID# 208081
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Ogaki Municipal Hospital /ID# 226010
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center /ID# 164437
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
NHO Fukuyama Medical Center /ID# 164439
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 164426
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 164433
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Sapporo Medical University Hospital /ID# 164432
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Sapporo IBD Clinic /ID# 225923
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-0919
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital /ID# 208488
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Aoyama Clinic /ID# 164425
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Hyogo Medical University Hospital /ID# 164424
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 169224
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Sameshima Hospital /ID# 211181
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Tokai University Hospital /ID# 209204
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Gokeikai Ofuna Chuo Hospital /ID# 169300
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
St. Marianna University Hospital /ID# 226728
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University Hospital /ID# 169226
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Colo-proctology Center Matsushima Clinic /ID# 225914
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
220-0045
Country
Japan
Facility Name
Showa University Fujigaoka Hospital /ID# 209555
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Mie University Hospital /ID# 203633
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center /ID# 164441
City
Yokkaichi-shi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Tohoku University Hospital /ID# 164430
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 202674
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Nara Medical University Hospital /ID# 169225
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kinshukai Infusion Clinic /ID# 226747
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital /ID# 226035
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saga University Hospital /ID# 209396
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Tokitokai Tokito clinic /ID# 164253
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
Shiga University of Medical Science Hospital /ID# 164440
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 226727
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Matsuda Hospital /ID# 226616
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
432-8061
Country
Japan
Facility Name
NHO Shizuoka Medical Center /ID# 164435
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital /ID# 164258
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 225822
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Tokai University Hachioji Hospital /ID# 226899
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Teikyo University Hospital /ID# 225588
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
The Jikei University Hospital /ID# 164434
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital /ID# 164256
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Kyorin University Hospital /ID# 164259
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
NTT Medical Center Tokyo /ID# 225587
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Keio University Hospital /ID# 203629
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Japanese Red Cross Wakayama Medical Center /ID# 171195
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
640-8558
Country
Japan
Facility Name
Wakayama Medical University Hospital /ID# 169487
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamagata University Hospital /ID# 171474
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Tokuyama Central Hospital /ID# 226011
City
Shunan-shi
State/Province
Yamaguchi
ZIP/Postal Code
745-8522
Country
Japan
Facility Name
Hanyang University Gurihospital /ID# 158702
City
Guri
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
CHA University Bundang Medical Center /ID# 158710
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 158707
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 158701
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Inje University Haeundae Hospital /ID# 203028
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Dong-A University Hospital /ID# 158705
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 158711
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center /ID# 158703
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 158704
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
VCA Polyclinic Aura /ID# 163802
City
Riga
ZIP/Postal Code
1035
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital /ID# 163803
City
Riga
ZIP/Postal Code
LV- 1002
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos /ID# 170614
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Universiti Sains Malaysia /ID# 221971
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
JM Research SC /ID# 203593
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud /ID# 203595
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Health Pharma Professional Research S.A de C.V /ID# 203597
City
Del. Benito Juárez
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Academisch Medisch Centrum /ID# 157959
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Elisabeth Tweesteden Ziekenhuis /ID# 163767
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Tauranga Hospital /ID# 212792
City
Tauranga South
State/Province
Bay Of Plenty
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Christchurch Hospital /ID# 205342
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital /ID# 212789
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Regional Hospital /ID# 205343
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Hutt Hospital /ID# 212786
City
Lower Hutt
ZIP/Postal Code
5010
Country
New Zealand
Facility Name
Dunedin Hospital /ID# 212790
City
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Vistamed /ID# 210105
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Vitamed Gałaj i Cichomski Sp.j. /ID# 213283
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Gastromed Sp. z o.o /ID# 230978
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Medyczne Plejady /ID# 170633
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-363
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus /ID# 216102
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 170597
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170601
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170600
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
NZOZ Vivamed Jadwiga Miecz /ID# 216307
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Endoskopia Sp. z o.o. /ID# 170598
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
NZOZ All-Medicus /ID# 170596
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-659
Country
Poland
Facility Name
H-T. Centrum Medyczne - Endoterapia /ID# 230979
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551
City
Portimão
State/Province
Faro
ZIP/Postal Code
8500-338
Country
Portugal
Facility Name
Centro Hospitalar de Entre Douro e Vouga /ID# 166052
City
Santa Maria Da Feira
State/Province
Porto
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Hospital Garcia de Orta, EPE /ID# 165583
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hosp de Tondela-Viseu /ID# 166053
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Ponce Medical School Foundation /ID# 221244
City
Ponce
ZIP/Postal Code
00716-0377
Country
Puerto Rico
Facility Name
San Jorge Children Hospital /ID# 166954
City
San Juan
ZIP/Postal Code
00912-3310
Country
Puerto Rico
Facility Name
VA Caribbean Healthcare System /ID# 221245
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Clinica GASTRO MED SRL /ID# 224169
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400380
Country
Romania
Facility Name
Sana Monitoring /Id# 224166
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
Fundeni Clinical Institute /ID# 171264
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Fundeni Clinical Institute /ID# 224168
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Duplicate_Centrul Medical Tuculanu SRL /ID# 171268
City
Timisoara
ZIP/Postal Code
300168
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed /ID# 171266
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Interdisctrict Multidisciplinary Hospital /ID# 203335
City
Anzorey
State/Province
Kabardino-Balkarskaya Respublika
ZIP/Postal Code
361350
Country
Russian Federation
Facility Name
GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973
City
Nalchik
State/Province
Kabardino-Balkarskaya Respublika
ZIP/Postal Code
360001
Country
Russian Federation
Facility Name
Immanuel Kant Baltic Federal University /ID# 204888
City
Kaliningrad
State/Province
Kaliningradskaya Oblast
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
Kuzbass Regional Clinical Hospital /ID# 165750
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Uninova Medical Center /ID# 229216
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
198218
Country
Russian Federation
Facility Name
Arsvita Clinic /ID# 208946
City
Korolev
State/Province
Moskovskaya Oblast
ZIP/Postal Code
141077
Country
Russian Federation
Facility Name
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
City Clinical Hospital #40 /ID# 203370
City
Sestroretsk
State/Province
Sankt-Peterburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1 /ID# 165754
City
Tyumen
State/Province
Tyumenskaya Oblast
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Clinic of New Technologies of Medicine /ID# 203369
City
Dzerzhinskiy
ZIP/Postal Code
140091
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a I.M. Sechenov /ID# 204978
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Central Clinical Hospital RZHD Medicine /ID# 204917
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Novosibirski Gastrocenter /ID# 229855
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Euromedservice /ID# 204892
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
International Medical Center SOGAZ /ID# 206727
City
St. Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital /ID# 203368
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Facility Name
Clinical Hosp Center Zvezdara /ID# 200151
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 200152
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 202059
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Vojvodina /ID# 156910
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
General Hospital Leskovac /ID# 207226
City
Leskovac
ZIP/Postal Code
16000
Country
Serbia
Facility Name
KL Ling Gastroenterology and Liver Clinic /ID# 205738
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
KM Management, spol. s.r.o. /ID# 206602
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
Facility Name
GASTRO I., s.r.o. /ID# 164346
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Univ Medical Ctr Ljubljana /ID# 210627
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Farmovs (Pty) Ltd /Id# 207537
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Clinresco Centers /ID# 239824
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Spoke Research Inc /ID# 229905
City
CAPE TOWN Milnerton
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Facility Name
Allergy & Immunology (AIU) /ID# 171441
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Dr JP Wright /ID# 171138
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 171137
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital de Cabuenes /ID# 170748
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33394
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro CHUVI /ID# 167360
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 159439
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia /ID# 167058
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 159459
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Pontevedra /ID# 216182
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario de Salamanca /ID# 159446
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 159968
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet /ID# 159445
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Alingsas lasarett /ID# 202074
City
Alingsas
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
441 33
Country
Sweden
Facility Name
Sahlgrenska University Hospital Molndal /ID# 202843
City
Molndal
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
431 80
Country
Sweden
Facility Name
Danderyds sjukhus AB /ID# 202035
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Universitatsspital Zurich /ID# 202910
City
Zurich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 202911
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Chung Shan Medical University Hospital /ID# 163651
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 160189
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital /ID# 163649
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 162187
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 163650
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 222877
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Acibadem Kozyatagi Hospital /ID# 213276
City
Kadikoy
State/Province
Istanbul
ZIP/Postal Code
34742
Country
Turkey
Facility Name
Erciyes University Medical Fac /ID# 171291
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 167210
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal /ID# 203981
City
Battalgazi/malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Uludag University Medical Faculty /ID# 204182
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Fırat University Medical Facul /ID# 171292
City
Elazig
ZIP/Postal Code
23100
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Sisli Etfal Train & Res Hosp /ID# 171409
City
Sisli
ZIP/Postal Code
34371
Country
Turkey
Facility Name
CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367
City
Ivano-frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18 /ID# 224348
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Medical Center "OK!Clinic+" /ID# 205482
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343
City
Kyiv
ZIP/Postal Code
04073
Country
Ukraine
Facility Name
Royal Devon University Healthcare NHS Foundation Trust /ID# 157587
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust /ID# 210813
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 157590
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Barnsley Hospital NHS Foundation Trust /ID# 202770
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 158040
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian /ID# 208802
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Liverpool University Hospitals NHS Foundation Trust /ID# 203858
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 158766
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust /ID# 208378
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com
Description
Related Info

Learn more about this trial

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

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