A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish)
Ulcerative Colitis (UC)
About this trial
This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring Upadacitinib, ABT-494, Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.
Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.
- Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
- Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
- Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.
- Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
- If female, participant must meet the contraception recommendation criteria.
Exclusion Criteria:
- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
- Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of Baseline.
- Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
- Screening laboratory and other analyses show any prespecified abnormal hematologic results.
Sites / Locations
- East View Medical Research, LLC /ID# 216933
- CB Flock Research Corporation /ID# 206094
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030
- Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887
- University of Arizona /ID# 208856
- Citrus Valley Gastroenterology /ID# 205627
- Care Access Research /ID# 217003
- Moore UC San Diego Cancer Center /ID# 204919
- United Medical Doctors /ID# 207867
- TLC Clinical Research Inc /ID# 216831
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314
- Facey Medical Foundation /ID# 205301
- United Medical Doctors - Murrieta /ID# 205313
- InSite Digestive Health Care - Oxnard /ID# 205628
- Inland Empire Clinical Trials, LLC /ID# 216164
- San Diego Clinical Trials /ID# 212122
- Medical Assoc Research Grp /ID# 205626
- Delta Waves, Inc. /ID# 206170
- Western States Clinical Res /ID# 206091
- Western Connecticut Medical Group /ID# 208290
- Gastroenterology Center of CT /ID# 208291
- Gastro Florida /ID# 206174
- Universal Axon Clinical Research /ID# 213462
- Palmetto Research, LLC /ID# 208293
- Nature Coast Clinical Research - Inverness /ID# 206087
- Encore Borland-Groover Clinical Research /Id# 208128
- Cfagi Llc /Id# 207995
- University of Miami /ID# 215445
- Coral Research Clinic /ID# 208292
- Advanced Research Institute, Inc /ID# 206077
- Endoscopic Research, Inc. /ID# 207360
- Omega Research Consultants /ID# 206066
- Clinical Research Trials of Florida, Inc. /ID# 206068
- University of South Florida /ID# 214495
- AdventHealth Tampa /ID# 207363
- Gastroenterology Associates of Central Georgia, LLC /ID# 216940
- Infinite Clinical Trials /ID# 215343
- Atlanta Gastroenterology Spec /ID# 206173
- Next Innovative Clinical Research - Chicago /ID# 217324
- The University of Chicago Medical Center /ID# 206172
- Carle Foundation Hospital /ID# 207397
- MediSphere Medical Research Center /ID# 206073
- Indianapolis Gastroenterology /ID# 206381
- University of Iowa Hospitals and Clinics /ID# 206167
- Cotton-O'Neil Clinical Res Ctr /ID# 206175
- Tri-State Gastroenterology /ID# 206124
- Houma Digestive Health Special /ID# 206176
- Louisana Research Center, LLC /ID# 206064
- Gastro Center of Maryland /ID# 206883
- University of Michigan Health Systems /ID# 206918
- Huron Gastroenterology Assoc /ID# 205109
- Clin Res Inst of Michigan, LLC /ID# 207078
- Revival Research Institute, LLC /ID# 207282
- Center for Digestive Health /ID# 207080
- Mayo Clinic /ID# 205645
- University of Mississippi Medical Center /ID# 213116
- Southern Therapy and Advanced Research (STAR) LLC /ID# 206069
- Las Vegas Medical Research /ID# 206814
- AGA Clinical Research Associates, LLC /ID# 206880
- Atlantic Digestive Health Inst /ID# 208748
- Rutgers Robert Wood Johnson /ID# 207382
- University of New Mexico Department of Internal Medicine /ID# 214397
- Advantage Clinical Trials /ID# 206082
- NY Scientific /ID# 206080
- NYU Langone Long Island Clinical Research Associates /ID# 206079
- DiGiovanna Institute for Medical Education & Research /ID# 206885
- Premier Medical Group - GI Division /ID# 206097
- Gastro Group of Rochester /ID# 206881
- Richmond University Medical Center /ID# 213185
- Digestive Health Partners, P.A /ID# 206842
- Atrium Health Carolinas Medical Center /ID# 206085
- Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138
- Wake Forest Baptist Medical Center /ID# 206067
- Duplicate_Plains Clinical Research Center, LLC /ID# 205111
- University of Cincinnati /ID# 205633
- The Ohio State University /ID# 205637
- Optimed Research, Ltd. /ID# 205638
- Hometown Urgent Care and Resea /ID# 205630
- Dayton Gastroenterology, Inc. /ID# 205639
- Great Lakes Gastroenterology Research LLC /ID# 205631
- Hightower Clinical /ID# 216336
- Digestive Disease Specialists /ID# 206076
- Options Health Research, LLC /ID# 206707
- Healthcare Research Consultant /ID# 206706
- Guthrie Medical Group, PC /ID# 206078
- Pharmacorp Clinical Trials /ID# 206074
- Gastroenterology Associates, P.A. of Greenville /ID# 206098
- Gastro One /ID# 206178
- East Tennessee Research Institute /ID# 206169
- Quality Medical Research /ID# 206088
- Vanderbilt University Medical Center /ID# 210405
- TX Clinical Research Institute /ID# 206718
- Inquest Clinical Research /ID# 206132
- Texas Digestive Disease Consultants /ID# 209805
- Texas Digestive Disease Consultants /ID# 209948
- Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484
- DHAT Research Institute /ID# 206716
- Vilo Research Group Inc /ID# 212625
- Baylor College of Medicine - Baylor Medical Center /ID# 206717
- Centex Studies, Inc. - Houston /ID# 206168
- GI Specialists of Houston /ID# 206090
- Caprock Gastro Research /ID# 215115
- Clinical Associates in Research Therapeutics of America, LLC /ID# 206710
- Southern Star Research Institute, LLC /ID# 205379
- Baylor Scott & White Center for Diagnostic Medicine /ID# 206096
- Duplicate_Tyler Research Institue /ID# 206075
- Gastro Health & Nutrition - Victoria /ID# 205378
- Advanced Research Institute /ID# 206133
- Ctr for Gastrointestinal Healt /ID# 208475
- Washington Gastroenterology Associates /ID# 206177
- Virginia Mason - Seattle Orthapedics /ID# 206070
- The Vancouver Clinic, INC. PS /ID# 204973
- Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917
- Froedtert Memorial Lutheran Hospital /ID# 206945
- Cardio Alem /ID# 211282
- Mautalen Salud e Investigacion /ID# 206033
- Hospital Britanico de Buenos Aires /ID# 209497
- Gedyt /ID# 210017
- Hospital Privado Univesitario /ID# 206030
- Macquarie University Hospital /ID# 211955
- Duplicate_Mater Misericordiae /ID# 212687
- Griffith University /ID# 211956
- St Vincent's Hospital Melbourne /ID# 205758
- Monash Medical Centre /ID# 206486
- Fiona Stanley Hospital /ID# 211642
- Klinik Landstrasse /ID# 205764
- Medical University of Vienna /ID# 205763
- LKH Salzburg and Paracelsus /ID# 208788
- Universitair Ziekenhuis Leuven /ID# 205988
- AZ Maria Middelares /ID# 210928
- University Clinical Centre of the Republic of Srpska /ID# 208053
- University Clinical Centre of the Republic of Srpska /ID# 208055
- University Clinical Center Tuzla /ID# 208057
- University Clinical Hospital Mostar /ID# 208054
- Clinical Center University of Sarajevo /ID# 208058
- Hospital Nossa Senhora das Graças /ID# 206981
- Hospital de Clinicas de Porto Alegre /ID# 206985
- Upeclin Fmb - Unesp /Id# 206986
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504
- Faculdade de Medicina do ABC /ID# 206984
- Kaiser Clinica e Hospital Dia /ID# 206982
- University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755
- Allen Whey Khye Lim Professional Corporation /ID# 211167
- Covenant Health /ID# 205500
- Percuro Clinical Research, Ltd /ID# 205501
- Duplicate_Toronto Digestive Disease Asso /ID# 205498
- Crchum /Id# 207387
- CIUSSS de l'Estrie - CHUS /ID# 205499
- Research Group /ID# 208037
- M y F Estudios Clínicos Ltda. /ID# 208035
- Hospital Guillermo Grant Benavente de Concepción /ID# 212426
- CTR Estudios Clinicos /ID# 208036
- Hospital Clinico Universidad De Los Andes /ID# 207426
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267
- The Sixth Affiliated Hosp Sun /ID# 205268
- Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266
- The First Affiliated Hospital of Nanchang University /ID# 212186
- The First Hospital of Jilin University /ID# 210088
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271
- West China Hospital, Sichuan University /ID# 205332
- Duplicate_Tianjin Med Univ General Hosp /ID# 205246
- Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265
- Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887
- Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886
- Hospital Universitario San Vic /ID# 208888
- Klinicka bolnica Dubrava Zagreb /ID# 208460
- Poliklinika Solmed /ID# 211568
- Klinicki bolnicki centar Rijeka /ID# 208650
- Klinicki bolnicki centar Split /ID# 217027
- Hepato-Gastroenterologie HK, s.r.o. /ID# 205672
- CTCenter MaVe s.r.o. /ID# 205671
- Artroscan s.r.o. /ID# 205668
- Nemocnice Pardubickeho kraje, a.s. /ID# 213540
- Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223
- Axon Clinical, s.r.o. /ID# 205670
- ISCARE a.s. /ID# 209240
- East Tallinn Central Hospital /ID# 207564
- West Tallinn Central Hospital /ID# 207356
- North Estonia Medical Centre /ID# 207357
- Tartu University Hospital /ID# 212282
- Tampere University Hospital /ID# 206161
- Keski-Suomen Sairaala Nova /ID# 206159
- Laakarikeskus Ikioma /ID# 205814
- Tyks /Id# 205813
- Chu de Nice-Hopital L'Archet Ii /Id# 209118
- Centre Hospitalier Lyon Sud /ID# 209121
- Universitatsklinikum Mannheim /ID# 206811
- Duplicate_Universitaetsklinikum Tuebingen /ID# 206737
- Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813
- Duplicate_Praxis am Bayrischen Platz /ID# 206733
- Agaplesion Markus Krankenhaus /ID# 206731
- Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791
- Medizinisches Versorgungszentrum Portal 10 /ID# 207137
- General Hospital of Athens Laiko /ID# 208671
- University General Hospital of Heraklion PA.G.N.I /ID# 207061
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332
- Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822
- Bekes Megyei Kozponti Korhaz /ID# 205885
- Semmelweis Egyetem /ID# 205883
- Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992
- Mentahaz Maganorvosi Kozpont /ID# 205882
- Beaumont Hospital /ID# 206509
- University Hospital Galway /ID# 218035
- Rambam Health Care Campus /ID# 206362
- Shaare Zedek Medical Center /ID# 206365
- A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351
- ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611
- Istituto Clinico Humanitas /ID# 206346
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350
- Nagoya City University Hospital /ID# 206058
- Nagoya University Hospital /ID# 206355
- Toyohashi Municipal Hospital /ID# 207625
- Ieda Hospital /ID# 207479
- Hirosaki National Hospital /ID# 206387
- Tokatsu Tsujinaka Hospital /ID# 214963
- Tsujinaka Hospital Kashiwanoha /ID# 209573
- Toho University Medical Center Sakura Hospital /ID# 207705
- Juntendo University Urayasu Hospital /ID# 208784
- Fukui Prefectural Hospital /ID# 210449
- Fukuoka University Chikushi Hospital /ID# 214405
- Saiseikai Fukuoka Genaral Hospital /ID# 209482
- Kurume University Hospital /ID# 206385
- Ogaki Municipal Hospital /ID# 208227
- NHO Fukuyama Medical Center /ID# 206295
- Hiroshima University Hospital /ID# 206464
- Asahikawa Medical University Hospital /ID# 206404
- Obihiro kosei Hospital /ID# 210424
- Sapporo Tokushukai Hospital /ID# 209448
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059
- Sapporo Medical University Hospital /ID# 206314
- Sapporo Higashi Tokushukai Hospital /ID# 208494
- Aoyama Clinic /ID# 206452
- Hyogo College of Medicine Hospital /ID# 206455
- Kanazawa University Hospital /ID# 206316
- Iwate Medical University Uchimaru Medical Center /ID# 207051
- Idzuro Imamura Hospital /ID# 207639
- Sameshima Hospital /ID# 207935
- St. Marianna University School of Medicine Hospital /ID# 209451
- Showa University Fujigaoka Hospital /ID# 208224
- Kyoto University Hospital /ID# 211809
- Mie University Hospital /ID# 206803
- Yokkaichi Hazu Medical Center /ID# 214348
- National Hospital Organization Sendai Medical Center /ID# 209528
- NHO Nagasaki Medical Center /ID# 210822
- Kenseikai Dongo Hospital /ID# 208101
- Saiseikai Niigata Hospital /ID# 209921
- Niigata University Medical & Dental Hospital /ID# 218049
- Ishida Clinic of IBD and Gastroenterology /ID# 210119
- Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646
- Okayama University Hospital /ID# 217925
- Kinshukai Infusion Clinic /ID# 207865
- Kitano Hospital /ID# 210397
- Japanese Red Cross Osaka Hospital /ID# 209478
- Osaka City University Hospital /ID# 206457
- Toyonaka Municipal Hospital /ID# 217082
- Saga University Hospital /ID# 209270
- Saitama Medical Center /ID# 206393
- Tokitokai Tokito clinic /ID# 206313
- National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710
- Shimane University School of Medicine /ID# 208905
- Hamamatsu University Hospital /ID# 206459
- NHO Shizuoka Medical Center /ID# 208785
- Tokyo Medical And Dental University, Medical Hospital /ID# 206453
- St.Luke's International Hospital /ID# 208076
- Tokai University Hachioji Hospital /ID# 208903
- Teikyo University Hospital /ID# 209866
- Center Hospital of the National Center for Global Health and Medicine /ID# 209532
- Tokyo Women's Medical University Hospital /ID# 206460
- Yamagata University Hospital /ID# 206465
- Tokuyama Central Hospital /ID# 216994
- Shoyukai Fujita Gastroenterological Hospital /ID# 216493
- Kangbuk Samsung Hospital /ID# 206960
- Dong-A University Hospital /ID# 206955
- Pusan National University Hospital /ID# 206956
- Yeungnam University Medical Center /ID# 206959
- Duplicate_CHA Bundang Medical Center /ID# 207432
- Yonsei University Health System, Severance hospital /ID# 206958
- Riga East Clinical Univ Hosp /ID# 206828
- P. Stradins Clinical Univ Hosp /ID# 206827
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052
- Klaipeda Seamens Hospital /ID# 208791
- Klaipeda University Hospital /ID# 208790
- Vilnius University Hospital /ID# 209051
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662
- Duplicate_Uni Malaya MC /ID# 208936
- Morales Vargas Centro de Investigacion S.C. /ID# 211326
- Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068
- Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067
- Erasmus Medisch Centrum /ID# 205280
- Akershus Universitetssykehus_MAIN /ID# 205293
- Universitetssykehuset Nord-Norge /ID# 205691
- Gastromed /Id# 216108
- Centrum Medyczne Reuma Park w Warszawie /ID# 212913
- Centrum Zdrowia MDM /ID# 205874
- NZOZ Vivamed /ID# 216697
- Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070
- Endoskopia Sp. z o.o. /ID# 212964
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554
- Centro Hospitalar de Entre Douro e Vouga /ID# 205563
- Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556
- Hospital Garcia de Orta, EPE /ID# 206143
- CCA Braga - Hospital de Braga /ID# 206144
- Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117
- Hospital Santo Antonio dos Cap /ID# 206145
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626
- Immanuel Kant Baltic Federal University /ID# 208264
- NW State Medical Univ na Mechn /ID# 208258
- Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653
- Medical Company Hepatolog /ID# 208261
- Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652
- Kazan State Medical University /ID# 208256
- Olla-Med Clinic /ID# 215335
- Republican hospital named after V.A. Baranov /ID# 206507
- Euromedservice /ID# 208265
- LLC Novaya Clinica /ID# 208260
- Clinical Hosp Center Zvezdara /ID# 205258
- Military Medical Academy /ID# 205257
- University Clinical Center Serbia /ID# 205256
- Clin Hosp Ctr Bezanijska Kosa /ID# 206413
- University Clinical Center of Nis /ID# 206411
- University Clinical Center Kragujevac /ID# 206410
- Clinical Center Vojvodina /ID# 205259
- General Hospital Leskovac /ID# 217881
- National University Hospital /ID# 209099
- Gleneagles Medical Centre /ID# 206954
- Tan Tock Seng Hospital /ID# 207663
- Medak s.r.o. /ID# 205191
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147
- B+B MED, s.r.o. /ID# 205213
- Fakultna nemocnica s poliklini /ID# 211372
- GASTRO I., s.r.o. /ID# 205148
- MD Search /ID# 208084
- Clinresco Centers /ID# 208083
- Lenasia Clinical Trial Centre /ID# 214359
- Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082
- Wits Clinical Research Site /ID# 208949
- Mediclinic Milnerton /ID# 207979
- Kingsbury Hospital /ID# 205281
- Private Practice Dr MN Rajabally /ID# 205273
- Hospital Clínico Universitario de Santiago-CHUS /ID# 204411
- Hospital Unversitario Marques de Valdecilla /ID# 216622
- Hospital Universitario Dr. Negrin /ID# 206905
- Hospital Universitario A Coruna - CHUAC /ID# 206907
- Hospital Clinic de Barcelona /ID# 206906
- Hospital Universitario Reina Sofia /ID# 204412
- Hospital Universitario Ramon y Cajal /ID# 204410
- Hospital Universitario La Paz /ID# 214540
- Hospital Clinico Universitario de Salamanca /ID# 205013
- Hospital Universitario y Politecnico La Fe /ID# 206904
- Kantonsspital St. Gallen /ID# 211310
- Universitaetsspital Basel /ID# 211381
- Inselspital, Universitaetsklinik /ID# 211312
- Universitaetsspital Zuerich /ID# 211308
- China Medical University Hosp /ID# 207845
- National Taiwan University Hospital /ID# 207847
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848
- Taipei Veterans General Hosp /ID# 207849
- Erciyes University Medical Fac /ID# 207506
- Gazi University Med. Faculty /ID# 208040
- Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507
- Umraniye Training and Res Hosp /ID# 208206
- Mersin University Medical /ID# 208039
- Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939
- Kyiv Regional Hospital /ID# 217373
- PE PMC Acinus, Medical and Diagnostic Center /ID# 217218
- Medical centre of CONSILIUM MEDICAL LLC /ID# 217447
- Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300
- Basingstoke & North Hampshire /ID# 207985
- Queen Elizabeth University Hos /ID# 205154
- Huddersfield Royal Infirmary /ID# 217660
- St. George's Healthcare NHS /ID# 208375
- Barts and the London NHS Trust /ID# 205153
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Upadacitinib 45 mg
Placebo
Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.