A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies (U-EXCEL)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Upadacitinib, ABT-494, Efficacy, Safety, Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
- Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants), in the opinion of the investigator.
Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
- If female, participant must meet the contraception recommendations.
Exclusion Criteria:
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
- Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Participant with ostomy or ileoanal pouch.
- Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
- Screening laboratory and other analyses show abnormal results.
Sites / Locations
- East View Medical Research, LLC /ID# 171176
- CB Flock Research Corporation /ID# 166185
- Delsol Research Management, Ll /Id# 170145
- HonorHealth Research Institute - Shea /ID# 164821
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803
- Southern California Res. Ctr. /ID# 169655
- Citrus Valley Gastroenterology /ID# 166173
- Hoag Memorial Hosp Presbyterian /ID# 222540
- United Medical Doctors /ID# 207449
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762
- Facey Medical Foundation /ID# 203136
- United Medical Doctors - Murrieta /ID# 164945
- Ucsd /Id# 164910
- Medical Assoc Research Grp /ID# 169706
- Univ of California San Francis /ID# 164944
- Care Access Research /ID# 167767
- Peak Gastroenterology Associates, PC /ID# 170143
- Delta Waves, Inc. /ID# 164776
- Western States Clinical Res /ID# 164760
- Medical Research Center of CT /ID# 164926
- Clinical Research of West Florida, Inc /ID# 205827
- Clinical Research of West Florida, Inc /ID# 208118
- Advanced Research - Coral Springs /ID# 218021
- Encore Borland-Groover Clinical Research /Id# 203499
- Ctr for Advanced Gastroenterol /ID# 165353
- Crystal Pharmacology Research /ID# 166081
- Coral Research Clinic /ID# 164890
- Advanced Research Institute, Inc /ID# 164921
- Endoscopic Research, Inc. /ID# 206136
- Omega Research Maitland, LLC /ID# 203481
- Clinical Research Trials of Florida, Inc. /ID# 203485
- AdventHealth Tampa /ID# 171167
- Gastroenterology Associates of Central Georgia, LLC /ID# 165478
- Gastroenterology Consultants PC - Roswell /ID# 218220
- Atlanta Gastroenterology Spec /ID# 164799
- Treasure Valley Medical Research /ID# 215032
- Rush University Medical Center /ID# 165497
- University of Chicago Medicine /ID# 165503
- DuPage Medical Group /ID# 205328
- MediSphere Medical Research Center /ID# 166175
- Indianapolis Gastroenterology /ID# 164938
- University of Iowa Hospitals and Clinics /ID# 165436
- Tri-State Gastroenterology /ID# 165496
- University of Louisville /ID# 165366
- University of Louisville /ID# 168572
- CroNOLA, LLC /ID# 164823
- Nola Research Works, LLC /ID# 164759
- Louisana Research Center, LLC /ID# 164894
- Johns Hopkins University School of Medicine /ID# 211941
- MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935
- Gastro Center of Maryland /ID# 171161
- Lahey Hospital and Medical Center /ID# 214726
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943
- Digestive Health Associates (DHA) - Farmington Hills /ID# 205793
- Center for Digestive Health /ID# 164822
- Clin Res Inst of Michigan, LLC /ID# 170133
- Mayo Clinic - Rochester /ID# 164783
- Southern Therapy and Advanced Research (STAR) LLC /ID# 165343
- Quality Clinical Research Inc. /ID# 170137
- Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578
- Las Vegas Medical Research /ID# 168588
- AGA Clinical Research Associates, LLC /ID# 164769
- Rutgers Robert Wood Johnson /ID# 166073
- Montefiore Medical Center - Moses Campus /ID# 166193
- Advantage Clinical Trials /ID# 168546
- NY Scientific /ID# 164931
- United Health Services Hospitals, Inc /ID# 217485
- NYU Langone Long Island Clinical Research Associates /ID# 164927
- The Mount Sinai Hospital /ID# 170257
- Columbia Univ Medical Center /ID# 164782
- Gastoenterology Group of Rochester /ID# 166177
- Richmond University Medical Center /ID# 201857
- Atrium Health Carolinas Medical Center /ID# 164932
- PMG Research of Charlotte /ID# 171160
- Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904
- Wake Forest Baptist Medical Center /ID# 164908
- Plains Clinical Research Center, LLC /ID# 170140
- Gastro Health Research /ID# 164791
- University of Cincinnati /ID# 164825
- Cleveland Clinic Main Campus /ID# 209231
- The Ohio State University /ID# 170141
- Optimed Research, Ltd. /ID# 205624
- Hometown Urgent Care and Resea /ID# 201291
- Dayton Gastroenterology, Inc. /ID# 167627
- Great Lakes Medical Research, LLC /ID# 202010
- Digestive Disease Specialists /ID# 201064
- Options Health Research, LLC /ID# 164820
- Healthcare Research Consultant /ID# 166195
- University of Pennsylvania /ID# 168430
- Pharmacorp Clinical Trials /ID# 164916
- Gastroenterology Associates, P.A. of Greenville /ID# 164771
- Rapid City Medical Center - GI Research /ID# 201735
- Gastro One /ID# 164826
- East Tennessee Research Institute /ID# 203613
- Quality Medical Research /ID# 205263
- Vanderbilt University Medical Center /ID# 164946
- TX Clinical Research Institute /ID# 164896
- Inquest Clinical Research /ID# 164785
- Texas Digestive Disease Consultants /ID# 209953
- Texas Digestive Disease Consultants /ID# 209801
- Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144
- CliniCore International, LLC /ID# 164902
- Baylor College of Medicine - Baylor Medical Center /ID# 164947
- Centex Studies, Inc. - Houston /ID# 201214
- GI Specialists of Houston /ID# 202339
- Caprock Gastro Research, LLC /ID# 215438
- Clinical Associates in Research Therapeutics of America, LLC /ID# 164786
- Southern Star Research Institute, LLC /ID# 169755
- Carl R. Meisner Medical Clinic /ID# 201061
- Tyler Research Institute, LLC /ID# 168687
- Gastro Health & Nutrition - Victoria /ID# 167812
- HP Clinical Research /ID# 164933
- Advanced Research Institute /ID# 164784
- Duplicate_Care Access Research /ID# 164794
- Velocity Clinical Research - Salt Lake City /ID# 166076
- Washington Gastroenterology /ID# 164824
- Virginia Mason Medical Center /ID# 164913
- The Vancouver Clinic, INC. PS /ID# 164918
- Allegiance Research Specialists /ID# 165346
- Cardio Alem /ID# 211285
- Hospital Italiano de Buenos Aires /ID# 215541
- Gedyt /ID# 210020
- Cemic /Id# 169182
- Hospital Provincial del Centenario /ID# 171252
- Hospital Privado Univesitario /ID# 169230
- Concord Repatriation General Hospital /ID# 171512
- Coral Sea Clinical Research institute /ID# 212988
- Mater Misericordiae Limited /ID# 204909
- Royal Adelaide Hospital /ID# 171514
- Box Hill Hospital /ID# 203736
- Fiona Stanley Hospital /ID# 171513
- Medizinische Universitaet Wien /ID# 169465
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470
- UCL Saint-Luc /ID# 200303
- CHU de Liege Sart Tilman /ID# 217534
- AZ Sint-Lucas /ID# 200302
- University Clinical Centre of the Republic of Srpska /ID# 208051
- University Clinical Center Tuzla /ID# 210325
- Clinical Center University of Sarajevo /ID# 203887
- Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852
- Hospital Nossa Senhora das Graças /ID# 166863
- Hospital de Clinicas de Porto Alegre /ID# 166862
- Upeclin Fmb - Unesp /Id# 166867
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866
- Faculdade de Medicina do ABC /ID# 208323
- Kaiser Clinica e Hospital Dia /ID# 166865
- UMHAT Kaspela EOOD /ID# 167613
- Duplicate_Second MHAT Sofia /ID# 167614
- MHAT Trakia /ID# 201679
- University of Calgary /ID# 166974
- Allen Whey Khye Lim Professional Corporation /ID# 168044
- University of Alberta - Zeidler Ledcor Centre /ID# 166971
- South Edmonton Gastroenterology Research Clinic /ID# 166978
- Fraser Clinical Trials Inc /ID# 166968
- GIRI Gastrointestinal Research Institute /ID# 166975
- QEII - Health Sciences Centre /ID# 169307
- London Health Sciences Center /ID# 221038
- Scott Shulman Medicine Professional Corporation /ID# 169066
- Taunton Surgical Centre /ID# 168043
- Ottawa Hospital Research Institute /ID# 212414
- Medicor Research Inc /ID# 166979
- Toronto Digestive Disease Asso /ID# 166972
- CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969
- Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120
- Royal Victoria Hospital / McGill University Health Centre /ID# 170119
- CIUSSS de l'Estrie - CHUS /ID# 170940
- Research Group /ID# 203179
- M y F Estudios Clínicos /ID# 169984
- Hospital Guillermo Grant Benavente de Concepción /ID# 212423
- CTR Estudios Clinicos /ID# 203941
- Hospital Clinico Universidad De Los Andes /ID# 207466
- Zhongshan Hospital Xiamen University /ID# 204984
- The First Affiliated Hospital, Sun Yat-sen University /ID# 205228
- Nanfang Hospital of Southern Medical University /ID# 204083
- The Sixth Affiliated Hosp Sun /ID# 204077
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081
- Nanjing Drum Tower Hospital /ID# 204900
- The First Affiliated Hospital of Nanchang University /ID# 204092
- The First Hospital of Jilin University /ID# 206868
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073
- Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076
- Beijing Friendship Hospital /ID# 204173
- The Second Xiangya Hospital of Central South University /ID# 204082
- Duplicate_Tianjin Med Univ General Hosp /ID# 206994
- Tongji Hospital Tongji Medical College of HUST /ID# 204088
- Hospital Pablo Tobon Uribe /ID# 202404
- Hospital Universitario San Vic /ID# 200029
- Clinical Hospital Dubrava /ID# 171185
- Klinicki bolnicki centar Sestre milosrdnice /ID# 205535
- Klinicki bolnicki centar Zagreb /ID# 171203
- Poliklinika Solmed /ID# 211519
- UHC Split /ID# 171191
- Zadar General Hospital /ID# 205536
- Nemocnice Ceske Budejovice a.s. /ID# 224389
- Hepato-Gastroenterologie HK, s.r.o. /ID# 171401
- ARTROSCAN s.r.o. /ID# 200790
- ResTrial s.r.o. /ID# 208653
- Herlev Hospital /ID# 202423
- Nordsjaellands Hospital /ID# 202424
- Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425
- Duplicate_Sjaellands Universitets Hospital /ID# 209445
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564
- National Hepatology and Tropical Medicine Research Institute /ID# 170989
- Air Force Specialized Hospital /ID# 170996
- National Liver Institute /ID# 170988
- West Tallinn Central Hospital /ID# 202785
- CHU Grenoble - Hopital Michallon /ID# 219034
- Clinique Jules Verne /ID# 219073
- CH Valenciennes /ID# 219035
- Universitatsklinikum Mannheim /ID# 168759
- Universitaetsklinikum Ulm /ID# 203560
- Universitaetsklinikum Erlangen /ID# 203552
- Universitaetsklinikum Frankfurt /ID# 203566
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757
- Gastroenterologie am Mexikoplatz /ID# 203575
- Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570
- Agaplesion Markus Krankenhaus /ID# 168758
- Universitaetsklinikum Halle (Saale) /ID# 207455
- Medizinisches Versorgungszentrum Portal 10 /ID# 200214
- General Hospital of Athens Ippokratio /ID# 167045
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104
- Tzaneio general hospital of Piraeus /ID# 206433
- University General Hospital of Heraklion PA.G.N.I /ID# 167044
- General Hospital of Thessaloniki Hippokrateio /ID# 208825
- Tuen Mun Hospital /ID# 171218
- Mohacsi Korhaz /ID# 209441
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547
- Debreceni Egyetem Klinikai Kozpont /ID# 216419
- Bugat Pal Korhaz /ID# 201893
- Szent Borbala Korhaz /ID# 209897
- Obudai Egeszsegugyi Centrum Kft. /ID# 201892
- Semmelweis Egyetem /ID# 210167
- Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724
- Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723
- Pest Megyei Flor Ferenc Korhaz /ID# 206154
- Mentahaz Maganorvosi Kozpont /ID# 201895
- Mercy University Hospital /ID# 206511
- Soroka University Medical Center /ID# 169913
- Tel Aviv Sourasky Medical Center /ID# 204877
- Assaf Harofeh Medical Center /ID# 204872
- Hadassah Medical Center-Hebrew University /ID# 169928
- Rabin Medical Center /ID# 202636
- Kaplan Medical Center /ID# 170276
- Policlinico Universitario Campus Bio-Medico /ID# 168183
- Azienda Ospedaliera San Camillo Forlanini /ID# 168184
- Istituto Clinico Humanitas /ID# 168185
- Fondazione PTV Policlinico Tor Vergata /ID# 168188
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187
- A.O. Per L'Emergenza Cannizzaro /ID# 168190
- Policlinico San Martino/Univer /ID# 168191
- ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181
- ASST Grande Ospedale Metropolitano Niguarda /ID# 170849
- Azienda Ospedaliero-Universitaria di Modena /ID# 201897
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189
- Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421
- Aichi Medical University Hospital /ID# 165971
- Nagoya City University Hospital /ID# 165970
- Nagoya University Hospital /ID# 165969
- Toyohashi Municipal Hospital /ID# 200175
- National Hospital Organization Hirosaki General Medical Center /ID# 165961
- Toho University Sakura Medical Center /ID# 165963
- Fukuoka University Chikushi Hospital /ID# 214404
- Kurume University Hospital /ID# 166012
- National Hospital Organization Takasaki General Medical Center /ID# 167127
- NHO Fukuyama Medical Center /ID# 167131
- Hiroshima University Hospital /ID# 166014
- Asahikawa Medical University Hospital /ID# 167120
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960
- Sapporo Medical University Hospital /ID# 167124
- Sapporo IBD Clinic /ID# 223561
- Aoyama Clinic /ID# 166009
- Hyogo College of Medicine College Hospital /Id# 165973
- Kanazawa University Hospital /ID# 169218
- Iwate Medical University Uchimaru Medical Center /ID# 202464
- Imamura General Hospital /ID# 227137
- Idzuro Imamura Hospital /ID# 206654
- Sameshima Hospital /ID# 206675
- Yokohama City University Medical Center /ID# 167128
- Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972
- Kyoto University Hospital /ID# 169889
- Yokkaichi Hazu Medical Center /ID# 167196
- Tohoku University Hospital /ID# 167122
- Nara Medical University Hospital /ID# 169219
- Kenseikai Dongo Hospital /ID# 208104
- Niigata University Medical & Dental Hospital /ID# 170045
- Ishida Clinic of IBD and Gastroenterology /ID# 167121
- Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010
- Okayama University Hospital /ID# 167356
- Kinshukai Infusion Clinic /ID# 218872
- Osaka Metropolitan University Hospital /ID# 166015
- Osaka University Hospital /ID# 169663
- Osaka Medical and Pharmaceutical University Hospital /ID# 206326
- Tokitokai Tokito clinic /ID# 165962
- Shiga University of Medical Science Hospital /ID# 167129
- Hamamatsu University Hospital /ID# 224352
- NHO Shizuoka Medical Center /ID# 167125
- Tokyo Medical And Dental University Hospital /ID# 165965
- Tokai University Hachioji Hospital /ID# 165967
- The Jikei University Hospital /ID# 167130
- Kyorin University Hospital /ID# 165966
- Tokyo Women's Medical University Hospital /ID# 205980
- Toyama Prefectural Central Hospital /ID# 217834
- Japanese Red Cross Wakayama Medical Center /ID# 200643
- Wakayama Medical University Hospital /ID# 169482
- Yamagata University Hospital /ID# 200157
- Hayang University GuriHospital /ID# 167587
- CHA University Bundang Medical Center /ID# 167592
- Kangbuk Samsung Hospital /ID# 167586
- Yonsei University Health System Severance Hospital /ID# 167590
- Inje University Haeundae Hospital /ID# 202630
- Dong-A University Hospital /ID# 167591
- Pusan National University Hospital /ID# 167589
- Kyungpook National University Hospital /ID# 207019
- Samsung Medical Center /ID# 167588
- Chung-Ang University Hostipal /ID# 207018
- VCA Polyclinic Aura /ID# 169498
- Pauls Stradins Clinical University Hospital /ID# 169519
- Digestive Disease Center Gastro /ID# 169508
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936
- Vilnius University Hospital Santaros Klinikos /ID# 203286
- Hospital Sultanah Bahiyah /ID# 202626
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773
- Universiti Sains Malaysia /ID# 200102
- Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579
- Morales Vargas Centro de Investigacion S.C. /ID# 203494
- Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238
- Radboud Universitair Medisch Centrum /ID# 166928
- Zuyderland Medisch Centrum /ID# 169700
- Onze Lieve Vrouwe Gasthuis /ID# 166929
- Academisch Medisch Centrum /ID# 166927
- Medisch Spectrum Twente /ID# 170298
- Vistamed /ID# 208572
- Malopolskie Centrum Kliniczne /ID# 202167
- WIP Warsaw IBD Point Profesor Kierkus /ID# 224301
- Centrum Zdrowia MDM /ID# 200491
- Centrum Medyczne Reuma Park /ID# 200490
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245
- Hospital Egas Moniz /ID# 170253
- Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607
- Hospital Garcia de Orta, EPE /ID# 170241
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248
- Mindful Medical Research /ID# 203358
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771
- Institutul Clinic Fundeni /ID# 167817
- Clinica GASTRO MED SRL /ID# 206369
- Cabinet Particular Policlinic Algomed /ID# 167818
- Immanuel Kant Baltic Federal University /ID# 203811
- LLC Medical Center /ID# 209236
- Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990
- LLC Novaya Klinika /ID# 206616
- Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997
- Kazan State Medical University /ID# 169638
- Olla-Med Clinic /ID# 208720
- P.A. Bayandin Murmansk Regiona /ID# 169639
- Republican hospital named after V.A. Baranov /ID# 206488
- Euromedservice /ID# 206610
- X7 Clinical Research Center /ID# 216350
- City Clinical Hospital No. 31 /ID# 208868
- Clinical Hosp Center Zvezdara /ID# 168214
- Military Medical Academy /ID# 168783
- University Clinical Center Serbia /ID# 168215
- Clin Hosp Ctr Bezanijska Kosa /ID# 168750
- University Clinical Center Kragujevac /ID# 205859
- Clinical Center Vojvodina /ID# 168213
- KL Ling Gastroenterology and Liver Clinic /ID# 217962
- Gleneagles Medical Centre /ID# 206531
- Tan Tock Seng Hospital /ID# 203160
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958
- KM Management, spol. s.r.o. /ID# 170201
- Univ Medical Ctr Ljubljana /ID# 217795
- Farmovs (Pty) Ltd /Id# 207535
- Lenasia Clinical Trial Centre /ID# 205145
- Wits Clinical Research Site /ID# 170852
- Allergy & Immunology (AIU) /ID# 171431
- Dr JP Wright /ID# 170887
- Private Practice Dr MN Rajabally /ID# 169853
- Hospital Universitari Son Espases /ID# 201998
- Hospital Universitario de Navarra /ID# 202355
- Hospital Universitario A Coruna - CHUAC /ID# 203910
- Hospital Clinic de Barcelona /ID# 201990
- Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645
- Hospital Juan Ramon Jimenez /ID# 201995
- Hospital Universitario La Paz /ID# 201994
- Hospital Universitario de Salamanca /ID# 206358
- Hospital Universitario Virgen Macarena /ID# 201993
- Hospital Clinico Universitario de Valencia /ID# 209657
- Hospital Universitario y Politecnico La Fe /ID# 201992
- Hallands Hospital Halmstad /ID# 170828
- Karolinska University Hospital Solna /ID# 224488
- Alingsas lasarett /ID# 170826
- Sodra Alvsborgs sjukhus /ID# 203077
- Sahlgrenska University Hospital /ID# 169171
- Universitätsspital Zürich /ID# 170998
- Inselspital, Universitätsspital Bern /ID# 170997
- China Medical University Hospital /ID# 169791
- Taichung Veterans General Hospital /ID# 169790
- National Taiwan University Hospital /ID# 169792
- Acibadem Kozyatagi Hospital /ID# 209406
- Erciyes University Medical Fac /ID# 171331
- Ankara Univ Medical Faculty /ID# 206409
- Inonu Universitesi Turgut Ozal /ID# 201268
- Mustafa Kemal University Medic /ID# 171336
- Istanbul University Istanbul Medical Faculty /ID# 171364
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332
- Mersin University Medical /ID# 171338
- Sisli Etfal Train & Res Hosp /ID# 171334
- Gazi Universitesi Tip Fakultes /ID# 217444
- Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738
- Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907
- Kyiv Municipal Clinical Hospital #18 /ID# 207889
- MNI KRC Kyiv Regional Clinical Hospital /ID# 202454
- Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908
- CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110
- South Eastern Health and Social Care Trust /ID# 205323
- Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383
- Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086
- Royal United Hospitals Bath /ID# 169074
- University Hospitals Birmingham NHS Foundation Trust /ID# 169070
- The Dudley Group NHS Foundation Trust /ID# 169069
- King's College Hospital NHS Foundation Trust /ID# 169072
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075
- Stockport NHS foundation trust /ID# 208719
- Taunton and Somerset NHS Foundation Trust /ID# 209665
- St George's University Hospitals NHS Foundation Trust /ID# 205552
- The Royal Wolverhampton NHS Trust /ID# 171382
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Upadacitinib
Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.