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
Ulcerative Colitis (UC)
About this trial
This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring ABBV-066, BI 655066
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.
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
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
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
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.