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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: risankizumab IV; Drug: placebo for risankizumab; Drug: risankizumab SC

• Study Type: Interventional
• Enrollment (Actual): 1558
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5016
    • Hospital Privado Univesitario /ID# 167779
  • Ciuadad Autonoma De Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1115
      • Gedyt /ID# 243423
    • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431
      • Cemic /Id# 167782
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Hospital Provincial del Centenario /ID# 170898
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Sanatorio 9 de Julio /ID# 167780
• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685
  • Niederoesterreich
    • St. Poelten, Niederoesterreich, Austria, 3100
      • Duplicate_Universitaetsklinikum St.Poelten /ID# 169048
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Medizinische Universitaet Graz /ID# 169053
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 169050
• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Ziekenhuis /ID# 211100
  • Liege, Belgium, 4000
    • CHU de Liege /ID# 200253
  • Liege, Belgium, 4000
    • Groupe Sante CHC - Clinique du MontLegia /ID# 200250
  • Bruxelles-Capitale
    • Brussels, Bruxelles-Capitale, Belgium, 1070
      • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 200039
  • Namur
    • Godinne, Namur, Belgium, 5530
      • CHU UCL Namur - site Godinne /ID# 200254
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 170812
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ-Delta /ID# 200040
• Brazil
  • Goias
    • Goiânia, Goias, Brazil, 74535-170
      • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679
  • Parana
    • Curitiba, Parana, Brazil, 80810-040
      • Hospital Nossa Senhora das Graças /ID# 157671
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre /ID# 157662
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-686
      • Upeclin Fmb - Unesp /Id# 157690
    • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660
    • Santo André, Sao Paulo, Brazil, 09060-870
      • Faculdade de Medicina do ABC /ID# 163995
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
      • Kaiser Clinica e Hospital Dia /ID# 157680
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela EOOD /ID# 200797
  • Sliven, Bulgaria, 8800
    • MHAT Hadzhi Dimitar /ID# 207945
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 210797
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Joanna - ISUL /ID# 209977
  • Sofia, Bulgaria, 1202
    • Second MHAT Sofia /ID# 200799
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 169111
    • Edmonton, Alberta, Canada, T5R 1W2
      • Allen Whey Khye Lim Professional Corporation /ID# 169767
    • Edmonton, Alberta, Canada, T6K 4B2
      • Covenant Health /ID# 169114
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials Inc /ID# 169102
    • Victoria, British Columbia, Canada, V8V 3M9
      • Percuro Clinical Research, Ltd /ID# 169109
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Center- University Hospital /ID# 169103
    • North Bay, Ontario, Canada, P1B 2H3
      • Scott Shulman Medicine Professional Corporation /ID# 169113
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Asso /ID# 169106
  • Quebec
    • Lévis, Quebec, Canada, G6V 3Z1
      • Hotel Dieu de Levis /ID# 214378
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108
    • Montreal, Quebec, Canada, H4A 3J1
      • Royal Victoria Hospital / McGill University Health Centre /ID# 169104
• Chile
  • Concepción, Chile, 4070038
    • Hospital Guillermo Grant Benavente de Concepción /ID# 210761
  • Talcahuano, Chile, 1740000
    • Hospital Las Higueras /ID# 167093
  • Araucania
    • Victoria, Araucania, Chile, 4720843
      • Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151
  • Region Metropolitana Santiago
    • Santiago, Region Metropolitana Santiago, Chile, 8207257
      • Complejo Asistencial Dr. Sotero del Rio /ID# 169385
    • Santiago, Region Metropolitana Santiago, Chile, 8350488
      • Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125
• China
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University /ID# 211198
  • Shenyang, China, 110022
    • Shengjing Hospital of China Medical University /ID# 211646
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University /ID# 211228
  • Beijing
    • Beijing, Beijing, China, 100032
      • Beijing Friendship Hospital /ID# 211066
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hosp Sun /ID# 211231
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University /ID# 213018
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University /ID# 212868
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College of HUST /ID# 211072
    • Wuhan, Hubei, China, 430022
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071
  • Jiangsu
    • Huaian, Jiangsu, China, 223399
      • Huai'an First People's Hospital /ID# 239196
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 227439
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital /ID# 211232
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital /ID# 218798
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 212183
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University /ID# 212278
  • Ningxia
    • Yinchuan City, Ningxia, China, 750000
      • General Hospital of Ningxia Medical University /ID# 213911
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital /ID# 211639
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504
  • Shanghai
    • Pudong New District, Shanghai, China, 200136
      • Shanghai East Hospital /ID# 218791
    • Shanghai, Shanghai, China, 200065
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233
    • Shanghai, Shanghai, China, 201600
      • Shanghai General Hospital /ID# 226190
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 211276
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025
    • Hangzhou, Zhejiang, China, 310018
      • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064
• Colombia
  • Medellin, Colombia, 50010
    • Hospital Universitario San Vic /ID# 171490
  • Cordoba
    • Monteria, Cordoba, Colombia, 230003
      • Oncomédica SAS /ID# 206937
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Clinical Hospital Dubrava /ID# 157475
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 157471
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 201917
  • Osjecko-baranjska Zupanija
    • Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
      • Klinicki bolnicki centar Osijek /ID# 157472
  • Splitsko-dalmatinska Zupanija
    • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
      • Klinicki bolnicki centar Split /ID# 157473
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne /ID# 239157
  • Ceske Budejovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice a.s. /ID# 225226
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o. /ID# 163395
  • Ostrava, Czechia, 708 52
    • Fakultni nemocnice Ostrava /ID# 225567
• Denmark
  • Hovedstaden
    • Copenhagen NV, Hovedstaden, Denmark, 2400
      • Bispebjerg and Frederiksberg Hospital /ID# 208945
    • Hvidovre, Hovedstaden, Denmark, 2650
      • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266
  • Sjælland
    • Roskilde, Sjælland, Denmark, 4000
      • Sjællands Universitetshospital /ID# 200033
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense University Hospital /ID# 205602
• Egypt
  • Alexandria, Egypt, 21131
    • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848
  • Alexandria, Egypt, 21131
    • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793
  • Alexandria, Egypt, 21131
    • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794
  • Cairo, Egypt
    • Air Force Specialized Hospital /ID# 170986
  • Menoufiya, Egypt, 35111
    • National Liver Institute /ID# 171040
• France
  • Nantes, France, 44300
    • Clinique Jules Verne /ID# 240976
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • Chu de Nice-Hopital L'Archet Ii /Id# 171577
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13015
      • APHM - Hopital Nord /ID# 225825
  • Gironde
    • Pessac, Gironde, France, 33604
      • CHU Bordeaux - Hopital Haut Leveque /ID# 171579
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 223779
  • Ile-de-France
    • Clichy, Ile-de-France, France, 92110
      • Hopital Beaujon /ID# 200092
    • Neuilly Sur Seine, Ile-de-France, France, 92200
      • Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249860
  • Loire
    • St. Priest En Jarez, Loire, France, 42270
      • CHU de SAINT ETIENNE - Hopital Nord /ID# 171580
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 200095
  • Somme
    • Amiens CEDEX 1, Somme, France, 80054
      • CHU Amiens-Picardie Site Sud /ID# 171576
• Germany
  • Berlin, Germany, 10787
    • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145
  • Berlin, Germany, 10825
    • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361
  • Berlin, Germany, 12203
    • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend /ID# 166153
  • Braunschweig, Germany, 38126
    • Stadtisches Klinikum Braunschweig /ID# 163687
  • Frankfurt am Main, Germany, 60431
    • Agaplesion Markus Krankenhaus /ID# 159356
  • Kassel, Germany, 34117
    • Gastroenterologie Opernstrasse /ID# 163683
  • Leipzig, Germany, 04103
    • EUGASTRO GmbH /ID# 219070
  • Lueneburg, Germany, 21339
    • Klinikum Lueneburg /ID# 163685
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033
  • München, Germany, 81377
    • LMU Klinikum Campus Grosshadern /ID# 210481
  • Regensburg, Germany, 93042
    • Universitaetsklinikum Regensburg /ID# 163686
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg /ID# 162034
    • Heidelberg, Baden-Wuerttemberg, Germany, 69121
      • Praxis fuer Gastroenterologie /ID# 166152
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • Universitatsklinikum Mannheim /ID# 162035
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 164992
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 159354
  • Nordrhein-Westfalen
    • Grevenbroich, Nordrhein-Westfalen, Germany, 41515
      • Praxiszentrum fuer Gastroenterologie /ID# 219069
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Universitaetsklinikum Koeln /ID# 164991
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480
  • Pireaus, Greece, 18454
    • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218
  • Thessaloniki, Greece, 54639
    • Theageneio Anticancer Hospital /ID# 165217
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 229189
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Laiko /ID# 206440
    • Athens, Attiki, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915
    • Piraeus, Attiki, Greece, 18536
      • Tzaneio general hospital of Piraeus /ID# 206439
  • Kriti
    • Heraklion, Kriti, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 165216
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 171103
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 163544
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 167403
  • HaDarom
    • Be'er Sheva, HaDarom, Israel, 8443901
      • Soroka University Medical Center /ID# 171100
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 211278
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 171099
• Italy
  • Catania, Italy, 95126
    • A.O. Per L'Emergenza Cannizzaro /ID# 164036
  • Milano, Italy, 20157
    • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda /ID# 170947
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena /ID# 201819
  • Rome, Italy, 00168
    • UOC Medicina Interna e Gastroe /ID# 155608
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • University of Catanzaro /ID# 200125
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Ospedale Sant Orsola Malpighi /ID# 155611
  • Genova
    • Genoa, Genova, Italy, 16132
      • Ospedale Policlinico San Martino /ID# 164031
  • Lazio
    • Rome, Lazio, Italy, 00128
      • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163992
    • Rome, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini /ID# 155612
    • Rome, Lazio, Italy, 00161
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226
  • Milano
    • Rho, Milano, Italy, 20017
      • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas /ID# 155610
  • Roma
    • Rome, Roma, Italy, 00133
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158018
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041
• Japan
  • Aichi
    • Nagakute-shi, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital /ID# 164332
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 164331
    • Nagoya-shi, Aichi, Japan, 457-8511
      • Daido Clinic /ID# 211479
    • Nagoya-shi, Aichi, Japan, 4668560
      • Nagoya University Hospital /ID# 164271
    • Toyoake-shi, Aichi, Japan, 470-1192
      • Fujita Health University Hospital /ID# 164261
  • Aomori
    • Hirosaki-shi, Aomori, Japan, 036-8545
      • National Hospital Organization Hirosaki General Medical Center /ID# 164252
  • Chiba
    • Abiko-shi, Chiba, Japan, 270-1168
      • Tokatsu Tsujinaka Hospital /ID# 164438
    • Chiba-shi, Chiba, Japan, 260-8677
      • Chiba University Hospital /ID# 209632
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Tsujinaka Hospital Kashiwanoha /ID# 208964
    • Sakura-shi, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center /ID# 164254
  • Fukuoka
    • Chikushino-shi, Fukuoka, Japan, 818-8502
      • Fukuoka University Chikushi Hospital /ID# 209055
    • Fukuoka-shi, Fukuoka, Japan, 810-0001
      • Saiseikai Fukuoka Genaral Hospital /ID# 225639
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital /ID# 226189
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 164427
  • Gifu
    • Gifu-shi, Gifu, Japan, 501-1194
      • Gifu University Hospital /ID# 208081
    • Ogaki-shi, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital /ID# 226010
  • Gunma
    • Takasaki-shi, Gunma, Japan, 370-0829
      • National Hospital Organization Takasaki General Medical Center /ID# 164437
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-8520
      • NHO Fukuyama Medical Center /ID# 164439
    • Hiroshima-shi, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital /ID# 164426
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 078-8510
      • Asahikawa Medical University Hospital /ID# 164433
    • Sapporo-shi, Hokkaido, Japan, 060-0033
      • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251
    • Sapporo-shi, Hokkaido, Japan, 060-8543
      • Sapporo Medical University Hospital /ID# 164432
    • Sapporo-shi, Hokkaido, Japan, 064-0919
      • Sapporo IBD Clinic /ID# 225923
    • Sapporo-shi, Hokkaido, Japan, 065-0033
      • Sapporo Higashi Tokushukai Hospital /ID# 208488
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0015
      • Aoyama Clinic /ID# 164425
    • Nishinomiya-shi, Hyogo, Japan, 663-8501
      • Hyogo Medical University Hospital /ID# 164424
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 169224
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 892-0846
      • Sameshima Hospital /ID# 211181
  • Kanagawa
    • Isehara-shi, Kanagawa, Japan, 259-1193
      • Tokai University Hospital /ID# 209204
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Gokeikai Ofuna Chuo Hospital /ID# 169300
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital /ID# 226728
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital /ID# 169226
    • Yokohama-shi, Kanagawa, Japan, 220-0045
      • Colo-proctology Center Matsushima Clinic /ID# 225914
    • Yokohama-shi, Kanagawa, Japan, 227-8501
      • Showa University Fujigaoka Hospital /ID# 209555
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 203633
    • Yokkaichi-shi, Mie, Japan, 510-0016
      • Yokkaichi Hazu Medical Center /ID# 164441
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 164430
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital /ID# 202674
  • Nara
    • Kashihara-shi, Nara, Japan, 634-8522
      • Nara Medical University Hospital /ID# 169225
  • Osaka
    • Osaka-shi, Osaka, Japan, 530-0011
      • Kinshukai Infusion Clinic /ID# 226747
    • Takatsuki-shi, Osaka, Japan, 569-8686
      • Osaka Medical and Pharmaceutical University Hospital /ID# 226035
  • Saga
    • Saga-shi, Saga, Japan, 849-8501
      • Saga University Hospital /ID# 209396
  • Saitama
    • Saitama-shi, Saitama, Japan, 336-0963
      • Tokitokai Tokito clinic /ID# 164253
  • Shiga
    • Otsu-shi, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital /ID# 164440
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 226727
    • Hamamatsu-shi, Shizuoka, Japan, 432-8061
      • Matsuda Hospital /ID# 226616
    • Sunto-gun, Shizuoka, Japan, 411-8611
      • NHO Shizuoka Medical Center /ID# 164435
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical And Dental University Hospital /ID# 164258
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital /ID# 225822
    • Hachioji-shi, Tokyo, Japan, 192-0032
      • Tokai University Hachioji Hospital /ID# 226899
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital /ID# 225588
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital /ID# 164434
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital /ID# 164256
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Kyorin University Hospital /ID# 164259
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo /ID# 225587
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 203629
  • Wakayama
    • Wakayama-shi, Wakayama, Japan, 640-8558
      • Japanese Red Cross Wakayama Medical Center /ID# 171195
    • Wakayama-shi, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital /ID# 169487
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 171474
  • Yamaguchi
    • Shunan-shi, Yamaguchi, Japan, 745-8522
      • Tokuyama Central Hospital /ID# 226011
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Hospital /ID# 203028
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital /ID# 158705
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital /ID# 158711
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center /ID# 158703
  • Daejeon, Korea, Republic of, 34943
    • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 158704
  • Gyeonggido
    • Guri, Gyeonggido, Korea, Republic of, 11923
      • Hanyang University Gurihospital /ID# 158702
    • Seongnam si, Gyeonggido, Korea, Republic of, 13496
      • CHA University Bundang Medical Center /ID# 158710
    • Suwon, Gyeonggido, Korea, Republic of, 16247
      • The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
      • Kangbuk Samsung Hospital /ID# 158707
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Yonsei University Health System Severance Hospital /ID# 158701
• Latvia
  • Riga, Latvia, 1035
    • VCA Polyclinic Aura /ID# 163802
  • Riga, Latvia, LV- 1002
    • Pauls Stradins Clinical University Hospital /ID# 163803
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos /ID# 170614
• Malaysia
  • Kelantan, Malaysia, 16150
    • Universiti Sains Malaysia /ID# 221971
• Mexico
  • Del. Benito Juárez, Mexico, 03810
    • Health Pharma Professional Research S.A de C.V /ID# 203597
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • JM Research SC /ID# 203593
  • Yucatan
    • Merida, Yucatan, Mexico, 97000
      • Unidad de Atencion Medica e Investigacion en Salud /ID# 203595
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum /ID# 157959
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth Tweesteden Ziekenhuis /ID# 163767
• New Zealand
  • Lower Hutt, New Zealand, 5010
    • Hutt Hospital /ID# 212786
  • Otago, New Zealand, 9016
    • Dunedin Hospital /ID# 212790
  • Bay Of Plenty
    • Tauranga South, Bay Of Plenty, New Zealand, 3112
      • Tauranga Hospital /ID# 212792
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital /ID# 205342
  • Waikato
    • Hamilton, Waikato, New Zealand, 3240
      • Waikato Hospital /ID# 212789
  • Wellington
    • Newtown, Wellington, New Zealand, 6021
      • Wellington Regional Hospital /ID# 205343
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 53-149
      • Vistamed /ID# 210105
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
      • Vitamed Gałaj i Cichomski Sp.j. /ID# 213283
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • Gastromed Sp. z o.o /ID# 230978
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-363
      • Centrum Medyczne Plejady /ID# 170633
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 00-728
      • WIP Warsaw IBD Point Profesor Kierkus /ID# 216102
    • Warszawa, Mazowieckie, Poland, 00-635
      • Centrum Zdrowia MDM /ID# 170597
    • Warszawa, Mazowieckie, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170600
    • Warszawa, Mazowieckie, Poland, 03-580
      • NZOZ Vivamed Jadwiga Miecz /ID# 216307
    • Warszawa, Mazowieckie, Poland, 02-507
      • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170601
  • Pomorskie
    • Sopot, Pomorskie, Poland, 81-756
      • Endoskopia Sp. z o.o. /ID# 170598
  • Slaskie
    • Katowice, Slaskie, Poland, 40-659
      • NZOZ All-Medicus /ID# 170596
    • Tychy, Slaskie, Poland, 43-100
      • H-T. Centrum Medyczne - Endoterapia /ID# 230979
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta, EPE /ID# 165583
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054
  • Lisboa, Portugal, 1169-050
    • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581
  • Viseu, Portugal, 3504-509
    • Centro Hosp de Tondela-Viseu /ID# 166053
  • Braga
    • Guimaraes, Braga, Portugal, 4835-044
      • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580
  • Faro
    • Portimão, Faro, Portugal, 8500-338
      • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551
  • Porto
    • Santa Maria Da Feira, Porto, Portugal, 4520-211
      • Centro Hospitalar de Entre Douro e Vouga /ID# 166052
• Puerto Rico
  • Ponce, Puerto Rico, 00716-0377
    • Ponce Medical School Foundation /ID# 221244
  • San Juan, Puerto Rico, 00912-3310
    • San Jorge Children Hospital /ID# 166954
  • San Juan, Puerto Rico, 00921-3201
    • VA Caribbean Healthcare System /ID# 221245
• Romania
  • Bucharest, Romania, 011025
    • Sana Monitoring /Id# 224166
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute /ID# 171264
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute /ID# 224168
  • Timisoara, Romania, 300168
    • Duplicate_Centrul Medical Tuculanu SRL /ID# 171268
  • Timișoara, Romania, 300002
    • Cabinet Particular Policlinic Algomed /ID# 171266
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400380
      • Clinica GASTRO MED SRL /ID# 224169
• Russian Federation
  • Dzerzhinskiy, Russian Federation, 140091
    • Clinic of New Technologies of Medicine /ID# 203369
  • Moscow, Russian Federation, 119992
    • First Moscow State Medical University n.a I.M. Sechenov /ID# 204978
  • Moscow, Russian Federation, 123423
    • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512
  • Moscow, Russian Federation, 129128
    • Central Clinical Hospital RZHD Medicine /ID# 204917
  • Novosibirsk, Russian Federation, 630007
    • Novosibirski Gastrocenter /ID# 229855
  • Pushkin, Russian Federation, 196603
    • Euromedservice /ID# 204892
  • St. Petersburg, Russian Federation, 191186
    • International Medical Center SOGAZ /ID# 206727
  • Ulyanovsk, Russian Federation, 432017
    • Ulyanovsk Regional Clinical Hospital /ID# 203368
  • Kabardino-Balkarskaya Respublika
    • Anzorey, Kabardino-Balkarskaya Respublika, Russian Federation, 361350
      • Interdisctrict Multidisciplinary Hospital /ID# 203335
    • Nalchik, Kabardino-Balkarskaya Respublika, Russian Federation, 360001
      • GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973
  • Kaliningradskaya Oblast
    • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
      • Immanuel Kant Baltic Federal University /ID# 204888
  • Kemerovskaya Oblast
    • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650099
      • Kuzbass Regional Clinical Hospital /ID# 165750
  • Leningradskaya Oblast
    • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 198218
      • Uninova Medical Center /ID# 229216
  • Moskovskaya Oblast
    • Korolev, Moskovskaya Oblast, Russian Federation, 141077
      • Arsvita Clinic /ID# 208946
  • Permskiy Kray
    • Perm, Permskiy Kray, Russian Federation, 614109
      • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457
  • Sankt-Peterburg
    • Sestroretsk, Sankt-Peterburg, Russian Federation, 197706
      • City Clinical Hospital #40 /ID# 203370
  • Tyumenskaya Oblast
    • Tyumen, Tyumenskaya Oblast, Russian Federation, 625023
      • Regional Clinical Hospital #1 /ID# 165754
• Serbia
  • Belgrade, Serbia, 11040
    • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926
  • Leskovac, Serbia, 16000
    • General Hospital Leskovac /ID# 207226
  • Beograd
    • Belgrade, Beograd, Serbia, 11000
      • Clinical Hosp Center Zvezdara /ID# 200151
    • Belgrade, Beograd, Serbia, 11000
      • University Clinical Center Serbia /ID# 200152
    • Belgrade, Beograd, Serbia, 11080
      • Clin Hosp Ctr Bezanijska Kosa /ID# 202059
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Clinical Center Vojvodina /ID# 156910
• Singapore
  • Singapore, Singapore, 228510
    • KL Ling Gastroenterology and Liver Clinic /ID# 205738
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347
  • Nitra, Slovakia, 949 01
    • KM Management, spol. s.r.o. /ID# 206602
  • Nove Zamky, Slovakia, 940 34
    • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099
  • Presov, Slovakia, 080 01
    • GASTRO I., s.r.o. /ID# 164346
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Univ Medical Ctr Ljubljana /ID# 210627
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Farmovs (Pty) Ltd /Id# 207537
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1619
      • Clinresco Centers /ID# 239824
  • Western Cape
    • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
      • Spoke Research Inc /ID# 229905
    • Cape Town, Western Cape, South Africa, 7700
      • Allergy & Immunology (AIU) /ID# 171441
    • Cape Town, Western Cape, South Africa, 7708
      • Dr JP Wright /ID# 171138
    • Cape Town, Western Cape, South Africa, 7800
      • Private Practice Dr MN Rajabally /ID# 171137
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 159439
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia /ID# 167058
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 159459
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario Universitario de Pontevedra /ID# 216182
  • Salamanca, Spain, 37711
    • Hospital Universitario de Salamanca /ID# 159446
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 159968
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet /ID# 159445
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440
  • Asturias
    • Gijon, Asturias, Spain, 33394
      • Hospital de Cabuenes /ID# 170748
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Hospital Alvaro Cunqueiro CHUVI /ID# 167360
• Sweden
  • Stockholm, Sweden, 182 88
    • Danderyds sjukhus AB /ID# 202035
  • Vastra Gotalands Lan
    • Alingsas, Vastra Gotalands Lan, Sweden, 441 33
      • Alingsas lasarett /ID# 202074
    • Molndal, Vastra Gotalands Lan, Sweden, 431 80
      • Sahlgrenska University Hospital Molndal /ID# 202843
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern /ID# 202911
  • Zuerich
    • Zurich, Zuerich, Switzerland, 8091
      • Universitatsspital Zurich /ID# 202910
• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital /ID# 163651
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 163649
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 160189
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 163650
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 162187
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 222877
• Turkey
  • Ankara, Turkey, 06590
    • Ankara Univ Medical Faculty /ID# 167210
  • Battalgazi/malatya, Turkey, 44280
    • Inonu Universitesi Turgut Ozal /ID# 203981
  • Bursa, Turkey, 16059
    • Uludag University Medical Faculty /ID# 204182
  • Elazig, Turkey, 23100
    • Fırat University Medical Facul /ID# 171292
  • Istanbul, Turkey, 34098
    • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207
  • Istanbul, Turkey, 34899
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293
  • Sisli, Turkey, 34371
    • Sisli Etfal Train & Res Hosp /ID# 171409
  • Istanbul
    • Kadikoy, Istanbul, Turkey, 34742
      • Acibadem Kozyatagi Hospital /ID# 213276
  • Kayseri
    • Melikgazi, Kayseri, Turkey, 38030
      • Erciyes University Medical Fac /ID# 171291
• Ukraine
  • Ivano-frankivsk, Ukraine, 76018
    • CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367
  • Kherson, Ukraine, 73000
    • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350
  • Kyiv, Ukraine, 01030
    • Kyiv Municipal Clinical Hospital #18 /ID# 224348
  • Kyiv, Ukraine, 02091
    • Medical Center "OK!Clinic+" /ID# 205482
  • Kyiv, Ukraine, 04073
    • CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Barnsley Hospital NHS Foundation Trust /ID# 202770
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust /ID# 158040
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 208802
  • Liverpool, United Kingdom, L7 8XP
    • Liverpool University Hospitals NHS Foundation Trust /ID# 203858
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust /ID# 158766
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041
  • Tooting, United Kingdom, SW17 0QT
    • St George's University Hospitals NHS Foundation Trust /ID# 208378
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon University Healthcare NHS Foundation Trust /ID# 157587
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust /ID# 210813
  • London, City Of
    • London, London, City Of, United Kingdom, E1 2ES
      • Barts Health NHS Trust /ID# 157590
• United States
  • California
    • Coronado, California, United States, 92118-1408
      • Southern California Res. Ctr. /ID# 169660
    • Irvine, California, United States, 92618
      • Hoag Memorial Hosp Presbyterian /ID# 218348
    • La Jolla, California, United States, 92037
      • UC San Diego Health System /ID# 160452
    • Los Alamitos, California, United States, 90720-3309
      • United Medical Doctors /ID# 158528
    • Los Angeles, California, United States, 90067-2001
      • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931
    • San Francisco, California, United States, 94115-3011
      • UCSF Center for Colitis and Crohn's Disease /ID# 201210
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center-West Hollywood /ID# 163851
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates, PC /ID# 165841
    • Lone Tree, Colorado, United States, 80124-6798
      • Rocky Mountain Pediatric Gastroenterology /ID# 207174
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of CT /ID# 160311
    • New Haven, Connecticut, United States, 06510
      • Yale Univ Digestive Diseases /ID# 213179
  • Florida
    • Clermont, Florida, United States, 34711
      • South Lake Pain Institute, Inc /ID# 162878
    • Maitland, Florida, United States, 32751-6108
      • Ctr for Advanced Gastroenterol /ID# 202811
    • Miami, Florida, United States, 33136
      • University of Miami /ID# 160471
    • Miami, Florida, United States, 33186-4643
      • Coral Research Clinic /ID# 158584
    • Miami, Florida, United States, 33193
      • South Florida Research Ph I-IV, Inc. /ID# 161848
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Naples /ID# 165212
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute, Inc /ID# 161938
    • Orlando, Florida, United States, 32803
      • Advent Health /ID# 160433
    • Orlando, Florida, United States, 32803
      • Endoscopic Research, Inc. /ID# 206711
    • Orlando, Florida, United States, 32808
      • Omega Research Group /ID# 203059
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group /ID# 169730
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida, Inc. /ID# 201783
    • Tampa, Florida, United States, 33613-4680
      • AdventHealth Tampa /ID# 170503
  • Georgia
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC /ID# 160523
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Spec /ID# 161372
  • Illinois
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 160521
    • Oak Lawn, Illinois, United States, 60453
      • DM Clinical Research/Southwest /ID# 165012
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University /ID# 167252
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 226602
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Res Ctr /ID# 160412
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Robley Rex VA Medical Center /ID# 218648
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Houma Digestive Health Special /ID# 158317
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research /ID# 206815
    • New Orleans, Louisiana, United States, 70115
      • Nola Research Works, LLC /ID# 161368
    • Shreveport, Louisiana, United States, 71105-6800
      • Louisana Research Center, LLC /ID# 201204
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524
    • Chesterfield, Michigan, United States, 48047
      • Clin Res Inst of Michigan, LLC /ID# 160327
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 200458
  • Nebraska
    • Omaha, Nebraska, United States, 68114-3723
      • Quality Clinical Research Inc. /ID# 167313
  • New York
    • New York, New York, United States, 10022
      • Weill Cornell Medicine /ID# 165887
    • New York, New York, United States, 10032-3725
      • Columbia Univ Medical Center /ID# 161934
    • New York, New York, United States, 10075
      • Lenox Hill Hospital /ID# 168470
    • New York, New York, United States, 10279
      • Manhattan Clinical Research, LLC /ID# 211805
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education & Research /ID# 171129
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center /ID# 161664
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Carolinas Medical Center /ID# 158512
    • Greenville, North Carolina, United States, 27834
      • Carolina Research /ID# 201090
  • North Dakota
    • Fargo, North Dakota, United States, 58104-5925
      • Plains Clinical Research Center, LLC /ID# 169732
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 209232
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 164714
    • Columbus, Ohio, United States, 43235
      • Optimed Research, Ltd. /ID# 167113
    • Mentor, Ohio, United States, 44060-6211
      • Great Lakes Gastroenterology Research, LLC /ID# 201777
    • Sylvania, Ohio, United States, 43560-2767
      • ProMedica Physicians Digestive Healthcare /ID# 215623
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists /ID# 170779
    • Tulsa, Oklahoma, United States, 74136-7823
      • Adult Gastroenterology Associates - Gen 1 Research /ID# 208867
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State Milton S. Hershey Medical Center /ID# 223563
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 166266
    • Wyomissing, Pennsylvania, United States, 19610-2002
      • Digestive Disease Associates, LTD /ID# 232407
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates, P.A. of Greenville /ID# 160472
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Gastro One /ID# 160418
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee Research Institute /ID# 168747
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 160580
  • Texas
    • Baytown, Texas, United States, 77521-2415
      • Inquest Clinical Research /ID# 165685
    • Cedar Park, Texas, United States, 78613-5028
      • Texas Digestive Disease Consultants /ID# 209950
    • Cedar Park, Texas, United States, 78613
      • GI Alliance /ID# 209798
    • Garland, Texas, United States, 75044-2208
      • DHAT Research Institute /ID# 158226
    • Houston, Texas, United States, 77017-2337
      • Vilo Research Group Inc /ID# 207656
    • Houston, Texas, United States, 77027-6812
      • CliniCore International, LLC /ID# 158218
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine - Baylor Medical Center /ID# 158221
    • Houston, Texas, United States, 77036
      • Precision Research Institute, LLC /ID# 201351
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc. - Houston /ID# 201222
    • Lubbock, Texas, United States, 79424-3017
      • Caprock Gastro Research, LLC /ID# 215432
    • San Antonio, Texas, United States, 78212
      • Clinical Associates in Research Therapeutics of America, LLC /ID# 161376
    • San Antonio, Texas, United States, 78229-5390
      • Southern Star Research Institute, LLC /ID# 168776
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Center for Diagnostic Medicine /ID# 204130
    • Tyler, Texas, United States, 75701-4464
      • Tyler Research Institute, LLC /ID# 166800
    • Victoria, Texas, United States, 77904
      • Gastro Health & Nutrition - Victoria /ID# 164321
  • Utah
    • Ogden, Utah, United States, 84403
      • Advanced Research Institute /ID# 160480
  • Virginia
    • Roanoke, Virginia, United States, 24014-1372
      • Gastroenterology Consultants of Southwest Virginia /ID# 218143
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center /ID# 160466

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Substudy 1, Induction Period 1: Double-blind Placebo IV; Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.	Drug: placebo for risankizumab; placebo for risankizumab
Experimental: Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV; Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV; Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV; Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV; Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC; Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC; risankizumab subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC; Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC; risankizumab subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV; Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo; Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Placebo Comparator: Substudy 2, Induction Period 1: Double-blind Placebo IV; Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.	Drug: placebo for risankizumab; placebo for risankizumab
Experimental: Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV; Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC; Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC; risankizumab subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC; Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.	Drug: risankizumab SC; risankizumab subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV; Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066
Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo; Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.	Drug: risankizumab IV; risankizumab intravenous (IV) infusion; Other Names: BI 655066; ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.	Week 12
Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 2: Occurrence of UC-related Hospitalizations	Participants with an UC-related event that results in admission to the hospital.	Baseline Through Week 12
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements	Percentage of participants who reported no nocturnal bowel movements.	Week 12
Sub-Study 2: Percentage of Participants Achieving No Tenesmus	Percentage of participants who reported no tenesmus.	Week 12
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	Week 12
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	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.	Week 12
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response per Adapted Mayo Score was defined as decrease from baseline in Adapted Mayo Score ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.	Week 12
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score	Clinical response per Partial Adapted Mayo Score (without endoscopy). The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score >= 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.	Week 4
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission was defined as endoscopy subscore of 0.	Week 12
Sub-Study 1: Percentage of Participants With Hospitalization	Participants with an event that results in admission to the hospital.	Through Week 12
Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)	Mucosal healing defined as endoscopic and histologic remission. Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	Week 12
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)	The US-SQ is a patient questionnaire to assess severity of Ulcerative Colitis (UC) related gastrointestinal symptoms (e.g., frequent bowel movements, abdominal pain, cramping) and non-gastrointestinal symptoms (e.g., joint pain and sleep difficulties). It consists of 17 questions and each question is answered on a scale from can be answered on a scale from 1 (Not at all/ never) to 5 (Very much/Always) with overall symptom score range from 17 to 85. A lower score indicates lower UC severity.	Baseline Through Week 12
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. The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.	Baseline Through Week 12
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component	The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.	Baseline Through Week 12
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component	The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.	Baseline through Week 12
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The FACIT-Fatigue Scale is a validated self-administered 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four-point Likert scale. 0 = not at all; = a little bit; = somewhat; = quite a bit; = very much The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.	Baseline Through Week 12
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries	Participants who underwent surgery related to UC.	Through Week 12
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease. Clinical Response is defined as a decrease from baseline in the Adapted Mayo Score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).	Week 12
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic Improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	Week 12
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)	Histologic-Endoscopic Mucosal Improvement is defined as an endoscopic subscore of 0 or 1 without evidence of friability and a Geboes score ≤ 3.1. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	Week 12
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission per endoscopy subscore. Endoscopic Remission: endoscopic subscore = 0.	Week 12
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). The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease. Clinical Response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo Score ≥ 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.	Week 4
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency	Percentage of participants who reported no bowel urgency. Bowel urgency was assessed by participants in a subject diary completed once a day.	Week 12
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain	Percentage of participants who reported no abdominal pain. Abdominal pain was assessed by participants in a subject diary completed once a day.	Week 12
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. Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	Week 12
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The FACIT-Fatigue Scale is a validated self-administered 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four-point Likert scale. 0 = not at all; = a little bit; = somewhat; = quite a bit; = very much The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.	Baseline to Week 12
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. The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.	Baseline to Week 12
Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week	Change in number of fecal incontinence episodes per week.	Baseline to Week 12
Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms	Change from baseline in number of days per week with sleep interrupted due to UC symptoms.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: ABBV-066; BI 655066
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Immunologic Factors; Physiological Effects of Drugs; Antibodies, Monoclonal
• Other Study ID Numbers: M16-067; 2016-004677-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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