A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (COMMAND)

January 16, 2026 updated by: AbbVie

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.

Study Overview

Status

Active, not recruiting

Conditions

Ulcerative Colitis (UC)

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1242

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Córdoba, Argentina, 5016
    - Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 167802
- Buenos Aires
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1431
    - Cemic /Id# 167805
- Buenos Aires F.D.
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1115
    - Gedyt /ID# 243424
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Hospital Provincial del Centenario /ID# 170896
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Sanatorio 9 de Julio /ID# 167803
Austria
- - Salzburg, Austria, 5020
    - Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 200686
- Lower Austria
  - Sankt Pölten, Lower Austria, Austria, 3100
    - Duplicate_Universitaetsklinikum St.Poelten /ID# 169049
- Styria
  - Graz, Styria, Austria, 8010
    - Duplicate_Medizinische Universitaet Graz /ID# 169052
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 216043
- Vienna
  - Vienna, Vienna, Austria, 1090
    - Medizinische Universitaet Wien /ID# 169051
Belgium
- - Liège, Belgium, 4000
    - CHU de Liege /ID# 200257
- Antwerpen
  - Bonheiden, Antwerpen, Belgium, 2820
    - Imelda Ziekenhuis /ID# 211101
- Brussels Capital
  - Anderlecht, Brussels Capital, Belgium, 1070
    - Universite Libre de Bruxelles - Hopital Erasme /ID# 200256
  - Brussels, Brussels Capital, Belgium, 1200
    - Cliniques Universitaires UCL Saint-Luc /ID# 200260
- Liege
  - Liège, Liege, Belgium, 4000
    - Groupe Sante CHC - Clinique du MontLegia /ID# 200255
- Namur
  - Yvoir, Namur, Belgium, 5530
    - Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 200259
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Universitair Ziekenhuis Leuven /ID# 170829
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - AZ-Delta /ID# 200258
Brazil
- Goiás
  - Goiânia, Goiás, Brazil, 74535-170
    - Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157683
- La Spezia
  - Santo André, La Spezia, Brazil, 09060-870
    - Faculdade de Medicina do ABC /ID# 163993
- Paraná
  - Curitiba, Paraná, Brazil, 80810-040
    - Hospital Nossa Senhora das Graças /ID# 157677
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre /ID# 157670
- São Paulo
  - Botucatu, São Paulo, Brazil, 18618-686
    - Upeclin Fmb - Unesp /Id# 157691
  - Ribeirão Preto, São Paulo, Brazil, 14049-900
    - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 157668
  - São José do Rio Preto, São Paulo, Brazil, 15015-110
    - Kaiser Clinica e Hospital Dia /ID# 157686
Bulgaria
- - Plovdiv, Bulgaria, 4001
    - Umbal Kaspela /ID# 200795
  - Sliven, Bulgaria, 8800
    - MHAT Hadzhi Dimitar /ID# 207947
  - Sofia, Bulgaria, 1431
    - UMHAT Sveti Ivan Rilski /ID# 210798
  - Sofia, Bulgaria, 1202
    - Duplicate_Second MHAT Sofia /ID# 200794
- Sofia
  - Sofiya, Sofia, Bulgaria, 1527
    - Hospital Tsaritsa Yoanna /ID# 209978
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Duplicate_University of Calgary /ID# 169125
  - Edmonton, Alberta, Canada, T5R 1W2
    - Allen Whey Khye Lim Professional Corporation /ID# 169770
  - Edmonton, Alberta, Canada, T6K 4B2
    - Covenant Health /ID# 169128
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - Fraser Clinical Trials Inc /ID# 169116
  - Victoria, British Columbia, Canada, V8V 3M9
    - Percuro Clinical Research, Ltd /ID# 169123
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - London Health Sciences Center- University Hospital /ID# 169117
  - North Bay, Ontario, Canada, P1B 2H3
    - Scott Shulman Medicine Professional Corporation /ID# 169127
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Toronto Digestive Disease Associates /ID# 169120
- Quebec
  - Lévis, Quebec, Canada, G6V 3Z1
    - Hotel Dieu de Levis /ID# 214379
  - Montreal, Quebec, Canada, H1T 2M4
    - CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital- McGill University Health Center /ID# 169118
Chile
- Bio-Bio
  - Concepción, Bio-Bio, Chile, 4070038
    - Hospital Guillermo Grant Benavente de Concepción /ID# 210762
  - Talcahuano, Bio-Bio, Chile, 1740000
    - Hospital Las Higueras /ID# 167094
- Región de la Araucanía
  - Victoria, Región de la Araucanía, Chile, 4720843
    - Duplicate_Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213152
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 8207257
    - Complejo Asistencial Dr. Sotero del Rio /ID# 169386
China
- Anhui
  - Hefei, Anhui, China, 230022
    - The First Affiliated Hospital of Anhui Medical University /ID# 211227
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100032
    - Beijing Friendship Hospital /ID# 211061
- Guangdong
  - Guangzhou, Guangdong, China, 510655
    - The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 211229
- Hebei
  - Shijiazhuang, Hebei, China, 050000
    - The Second Hospital of Hebei Medical University /ID# 213019
- Hubei
  - Wuhan, Hubei, China, 430060
    - Renmin Hospital of Wuhan University /ID# 212867
  - Wuhan, Hubei, China, 430030
    - Tongji Hospital Tongji Medical College of HUST /ID# 211069
  - Wuhan, Hubei, China, 430048
    - Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211070
- Hunan
  - Changsha, Hunan, China, 410011
    - The Second Xiangya Hospital Of Central South University /ID# 211196
- Jiangsu
  - Huaian, Jiangsu, China, 223399
    - Huai'an First People's Hospital /ID# 239197
  - Nanjing, Jiangsu, China, 210008
    - Nanjing Drum Tower Hospital /ID# 227438
  - Nanjing, Jiangsu, China, 210029
    - Jiangsu Province Hospital /ID# 211234
  - Wuxi, Jiangsu, China, 214023
    - Wuxi People's Hospital /ID# 218797
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - The First Affiliated Hospital of Nanchang University /ID# 212182
- Jilin
  - Changchun, Jilin, China, 130021
    - The First Hospital of Jilin University /ID# 212277
- Liaoning
  - Shenyang, Liaoning, China, 110022
    - Shengjing Hospital of China Medical University /ID# 211643
- Ningxia
  - Yinchuan, Ningxia, China, 750000
    - General Hospital of Ningxia Medical University /ID# 213912
- Shaanxi
  - Xi'an, Shaanxi, China, 710032
    - Xijing Hospital /ID# 210708
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200065
    - Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210960
  - Shanghai, Shanghai Municipality, China, 200127
    - Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211230
  - Shanghai, Shanghai Municipality, China, 200136
    - Shanghai East Hospital /ID# 218796
  - Shanghai, Shanghai Municipality, China, 201600
    - Shanghai General Hospital /ID# 226652
- Shanxi
  - Xi’an, Shanxi, China, 710038
    - Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215505
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - West China Hospital, Sichuan University /ID# 211275
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 211024
  - Hangzhou, Zhejiang, China, 310018
    - Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211062
Colombia
- Antioquia
  - Medellín, Antioquia, Colombia, 50010
    - Fundación Hospitalaria San Vicente de Paul /ID# 171488
- Cundinamarca
  - Bogota DC, Cundinamarca, Colombia, 111221
    - Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 158736
- Departamento de Córdoba
  - Montería, Departamento de Córdoba, Colombia, 230018
    - Imat Oncomedica /ID# 207041
Croatia
- City of Zagreb
  - Zagreb, City of Zagreb, Croatia, 10000
    - Clinical Hospital Dubrava /ID# 157598
  - Zagreb, City of Zagreb, Croatia, 10000
    - Klinicki bolnicki centar Zagreb /ID# 157594
  - Zagreb, City of Zagreb, Croatia, 10000
    - Klinicki bolnicki centar Zagreb /ID# 201915
- County of Osijek-Baranja
  - Osijek, County of Osijek-Baranja, Croatia, 31000
    - Poliklinika Borzan d.o.o. /ID# 157595
- Split-Dalmatia County
  - Split, Split-Dalmatia County, Croatia, 21000
    - Klinicki Bolnicki Centar (KBC) Split /ID# 157596
Czechia
- - Hradec Králové, Czechia, 500 12
    - Hepato-Gastroenterologie HK, s.r.o. /ID# 163389
  - České Budějovice, Czechia, 370 01
    - Nemocnice Ceske Budejovice a.s. /ID# 225228
- Brno-mesto
  - Brno, Brno-mesto, Czechia, 656 91
    - Duplicate_Fakultni nemocnice u sv. Anny v Brne /ID# 239158
- Ostrava-mesto
  - Ostrava, Ostrava-mesto, Czechia, 708 52
    - Fakultni Nemocnice Ostrava /ID# 225568
- South Moravian
  - Brno, South Moravian, Czechia, 602 00
    - SurGal Clinic /ID# 252300
Denmark
- Capital Region
  - Copenhagen NV, Capital Region, Denmark, 2400
    - Bispebjerg and Frederiksberg Hospital /ID# 208953
  - Hvidovre, Capital Region, Denmark, 2650
    - Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 205093
- Region Sjælland
  - Roskilde, Region Sjælland, Denmark, 4000
    - Duplicate_Sjællands Universitetshospital /ID# 200073
- Region Syddanmark
  - Odense C, Region Syddanmark, Denmark, 5000
    - Duplicate_Odense Universitets Hospital /ID# 209502
Egypt
- - Alexandria, Egypt, 21131
    - Duplicate_Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 201824
  - Cairo, Egypt
    - Air Force Specialized Hospital /ID# 170984
- Alexandria Governorate
  - Alexandria, Alexandria Governorate, Egypt, 21131
    - Alexandria University /ID# 226795
  - Alexandria, Alexandria Governorate, Egypt, 21131
    - Alexandria University /ID# 226796
- Monufia Governorate
  - Menoufiya, Monufia Governorate, Egypt, 35111
    - National Liver Institute /ID# 171042
France
- - Nantes, France, 44300
    - Clinique Jules Verne /ID# 240977
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06202
    - Chu de Nice-Hopital Larchet Ii /Id# 207881
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, France, 13015
    - APHM - Hopital Nord /ID# 225826
- Herault
  - Montpellier, Herault, France, 34295
    - CHU Montpellier - Hopital Saint Eloi /ID# 223781
- Meurthe-et-Moselle
  - Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
    - Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 207877
- Nouvelle-Aquitaine
  - Pessac, Nouvelle-Aquitaine, France, 33604
    - Centre Hospitalier Universitaire de Bordeaux /ID# 207883
- Pays de la Loire Region
  - Saint Priest EN Jarez, Pays de la Loire Region, France, 42270
    - Duplicate_CHU de SAINT ETIENNE - Hopital Nord /ID# 207882
- Somme
  - Amiens, Somme, France, 80054
    - Duplicate_CHU Amiens-Picardie Site Sud /ID# 207880
- Île-de-France Region
  - Clichy, Île-de-France Region, France, 92110
    - Hopital Beaujon /ID# 207876
  - Neuilly-sur-Seine, Île-de-France Region, France, 92200
    - Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249861
Germany
- - Berlin, Germany, 10787
    - Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219146
  - Berlin, Germany, 10825
    - MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159380
  - Berlin, Germany, 12203
    - Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210508
  - Berlin, Germany, 14050
    - DRK Kliniken Berlin Westend /ID# 166155
  - Braunschweig, Germany, 38126
    - Stadtisches Klinikum Braunschweig /ID# 163694
  - Regensburg, Germany, 93042
    - Universitaetsklinikum Regensburg /ID# 163693
- Baden-Wurttemberg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    - Universitaetsklinikum Freiburg /ID# 162038
  - Heidelberg, Baden-Wurttemberg, Germany, 69121
    - Praxis fuer Gastroenterologie /ID# 166154
  - Mannheim, Baden-Wurttemberg, Germany, 68167
    - Universitatsklinikum Mannheim /ID# 162039
  - Ulm, Baden-Wurttemberg, Germany, 89081
    - Universitaetsklinikum Ulm /ID# 164994
- Bavaria
  - Erlangen, Bavaria, Germany, 91054
    - Universitaetsklinikum Erlangen /ID# 159373
  - Munich, Bavaria, Germany, 81377
    - Duplicate_LMU Klinikum Campus Grosshadern /ID# 210484
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60431
    - Duplicate_Agaplesion Markus Krankenhaus /ID# 159375
  - Kassel, Hesse, Germany, 34117
    - Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 163690
- Lower Saxony
  - Lüneburg, Lower Saxony, Germany, 21339
    - Klinikum Lueneburg /ID# 163692
- North Rhine-Westphalia
  - Cologne, North Rhine-Westphalia, Germany, 50937
    - Universitaetsklinikum Koeln /ID# 164993
  - Grevenbroich, North Rhine-Westphalia, Germany, 41515
    - Praxiszentrum fuer Gastroenterologie /ID# 219072
  - Minden, North Rhine-Westphalia, Germany, 32423
    - Gastroenterologische Gemeinschaftspraxis Minden /ID# 162037
- Saxony
  - Leipzig, Saxony, Germany, 04103
    - Eugastro /ID# 219071
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159379
Greece
- - Athens, Greece, 10676
    - General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217479
  - Thessaloniki, Greece, 54639
    - Theageneio Anticancer Hospital /ID# 165329
- Attica
  - Athens, Attica, Greece, 11527
    - General Hospital of Athens Ippokratio /ID# 229190
  - Athens, Attica, Greece, 11527
    - General Hospital of Athens Laiko /ID# 206438
  - Athens, Attica, Greece, 11527
    - General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170910
  - Nikaia, Attica, Greece, 18454
    - General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 165313
  - Piraeus, Attica, Greece, 18536
    - Tzaneio general hospital of Piraeus /ID# 206437
- Crete
  - Heraklion, Crete, Greece, 71500
    - University General Hospital of Heraklion PA.G.N.I /ID# 165327
Israel
- - Haifa, Israel, 3109601
    - Rambam Health Care Campus /ID# 171096
  - Petah Tikva, Israel, 4941492
    - Rabin Medical Center. /ID# 167402
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center /ID# 163543
  - Jerusalem, Jerusalem, Israel, 91120
    - Hadassah Medical Center-Hebrew University /ID# 171092
- Southern District
  - Beersheba, Southern District, Israel, 8443901
    - Soroka University Medical Center /ID# 171093
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 5265601
    - The Chaim Sheba Medical Center /ID# 211279
Italy
- - Bologna, Italy, 40138
    - IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 155627
  - Catania, Italy, 95126
    - Ospedale Cannizzaro /ID# 164039
  - Catanzaro, Italy, 88100
    - Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 200124
  - Modena, Italy, 41124
    - Azienda Ospedaliero-Universitaria di Modena /ID# 201818
  - Roma, Italy, 00128
    - Fondazione Policlinico Universitario Campus Bio-Medico /ID# 163994
  - Rome, Italy, 00168
    - UOC Medicina Interna e Gastroe /ID# 155624
- Genova
  - Genoa, Genova, Italy, 16132
    - Ospedale San Martino /ID# 164030
- Lombardy
  - Rozzano, Lombardy, Italy, 20089
    - IRCCS Istituto Clinico Humanitas /ID# 155626
- Milano
  - Milan, Milano, Italy, 20157
    - ASST Fatebenefratelli Sacco /ID# 155623
  - Milan, Milano, Italy, 20162
    - ASST Grande Ospedale Metropolitano Niguarda /ID# 170959
  - Rho, Milano, Italy, 20017
    - ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211450
- Roma
  - Rome, Roma, Italy, 00133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158020
  - Rome, Roma, Italy, 00149
    - Azienda Ospedaliera San Camillo Forlanini /ID# 155628
  - Rome, Roma, Italy, 00161
    - Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171223
- Verona
  - Negrar, Verona, Italy, 37024
    - IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164029
Japan
- - Tokyo, Japan, 173-8605
    - Teikyo University Hospital /ID# 225594
  - Tokyo, Japan, 105-8461
    - The Jikei University Hospital /ID# 164279
- Aichi-ken
  - Nagakute, Aichi-ken, Japan, 480-1195
    - Aichi Medical University Hospital /ID# 164227
  - Nagoya, Aichi-ken, Japan, 457-8511
    - Daido Clinic - Nagoya /ID# 211478
  - Nagoya, Aichi-ken, Japan, 4668560
    - Duplicate_Nagoya University Hospital /ID# 164230
  - Nagoya, Aichi-ken, Japan, 467-8602
    - Nagoya City University Hospital /ID# 164229
  - Toyoake, Aichi-ken, Japan, 470-1192
    - Fujita Health University Hospital /ID# 164313
- Aomori
  - Hirosaki-shi, Aomori, Japan, 036-8545
    - National Hospital Organization Hirosaki General Medical Center /ID# 164216
- Chiba
  - Abiko-shi, Chiba, Japan, 270-1168
    - Tokatsu Tsujinaka Hospital /ID# 164310
  - Chiba, Chiba, Japan, 260-8677
    - Chiba University Hospital /ID# 209633
  - Kashiwa-shi, Chiba, Japan, 277-0871
    - Tsujinaka Hospital - Kashiwanoha /ID# 225968
  - Sakura-shi, Chiba, Japan, 285-8741
    - Toho University Sakura Medical Center /ID# 164219
- Fukuoka
  - Chikushino-shi, Fukuoka, Japan, 818-8502
    - Fukuoka University Chikushi Hospital /ID# 209056
  - Fukuoka, Fukuoka, Japan, 810-0001
    - Saiseikai Fukuoka Genaral Hospital /ID# 225640
  - Fukuoka, Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital /ID# 226723
  - Kurume-shi, Fukuoka, Japan, 830-0011
    - Kurume University Hospital /ID# 164237
- Gifu
  - Gifu, Gifu, Japan, 501-1194
    - Gifu University Hospital /ID# 208490
  - Ogaki-shi, Gifu, Japan, 503-8502
    - Ogaki Municipal Hospital /ID# 226009
- Gunma
  - Takasaki-shi, Gunma, Japan, 370-0829
    - National Hospital Organization Takasaki General Medical Center /ID# 164312
- Hiroshima
  - Fukuyama-shi, Hiroshima, Japan, 720-8520
    - National Hospital Organization Fukuyama Medical Center /ID# 164315
  - Hiroshima, Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital /ID# 164240
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 078-8510
    - Duplicate_Asahikawa Medical University Hospital /ID# 164324
  - Sapporo, Hokkaido, Japan, 060-8543
    - Sapporo Medical University Hospital /ID# 164278
  - Sapporo, Hokkaido, Japan, 060-0033
    - Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164215
  - Sapporo, Hokkaido, Japan, 064-0919
    - Sapporo IBD Clinic /ID# 225967
  - Sapporo, Hokkaido, Japan, 065-0033
    - Sapporo Higashi Tokushukai Hospital /ID# 208493
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0015
    - Aoyama Clinic /ID# 164236
  - Nishinomiya-shi, Hyōgo, Japan, 663-8501
    - Hyogo Medical University Hospital /ID# 164238
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8641
    - Kanazawa University Hospital /ID# 169221
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Japan, 892-0846
    - Sameshima Hospital /ID# 211182
- Kanagawa
  - Isehara, Kanagawa, Japan, 259-1193
    - Tokai University Hospital /ID# 209207
  - Kamakura-shi, Kanagawa, Japan, 247-0056
    - Gokeikai Ofuna Chuo Hospital /ID# 169296
  - Kawasaki-shi, Kanagawa, Japan, 216-8511
    - St Marianna University School Of Medicine /ID# 226730
  - Sagamihara-shi, Kanagawa, Japan, 252-0375
    - Kitasato University Hospital /ID# 169223
  - Yokohama, Kanagawa, Japan, 220-0041
    - Matsushima Hospital /ID# 254448
  - Yokohama, Kanagawa, Japan, 220-0045
    - Colo-proctology Center Matsushima Clinic /ID# 225915
  - Yokohama, Kanagawa, Japan, 227-8501
    - SHOWA Medical University Fujigaoka Hospital /ID# 209606
- Mie-ken
  - Tsu, Mie-ken, Japan, 514-8507
    - Mie University Hospital /ID# 203635
  - Yokkaichi-shi, Mie-ken, Japan, 510-0016
    - Yokkaichi Hazu Medical Center /ID# 164316
- Miyagi
  - Sendai, Miyagi, Japan, 9808574
    - Tohoku University Hospital /ID# 164276
- Nagasaki
  - Nagasaki, Nagasaki, Japan, 852-8501
    - Duplicate_Nagasaki University Hospital /ID# 205326
- Nara
  - Kashihara-shi, Nara, Japan, 634-8522
    - Nara Medical University Hospital /ID# 169222
- Osaka
  - Osaka, Osaka, Japan, 530-0011
    - Kinshukai Infusion Clinic /ID# 226992
  - Takatsuki-shi, Osaka, Japan, 569-8686
    - Osaka Medical and Pharmaceutical University Hospital /ID# 226036
- Saga-ken
  - Saga, Saga-ken, Japan, 849-8501
    - Saga University Hospital /ID# 209273
- Saitama
  - Saitama-shi, Saitama, Japan, 336-0963
    - Tokitokai Tokito clinic /ID# 164218
- Shiga
  - Ōtsu, Shiga, Japan, 520-2192
    - Shiga University of Medical Science Hospital /ID# 164323
- Shizuoka
  - Hamamatsu, Shizuoka, Japan, 431-3192
    - Hamamatsu University Hospital /ID# 226729
  - Hamamatsu, Shizuoka, Japan, 432-8061
    - Matsuda Hospital - Hamamatsu /ID# 226831
  - Sunto-gun, Shizuoka, Japan, 411-8611
    - NHO Shizuoka Medical Center /ID# 164314
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8519
    - Institute of Science Tokyo Hospital /ID# 164225
  - Chuo-ku, Tokyo, Japan, 104-8560
    - St. Lukes International Hospital /ID# 225969
  - Hachioji-shi, Tokyo, Japan, 192-0032
    - Tokai University Hachioji Hospital /ID# 227102
  - Minato-ku, Tokyo, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital /ID# 164222
  - Mitaka-shi, Tokyo, Japan, 181-8611
    - Kyorin University Hospital /ID# 164226
  - Shinagawa-ku, Tokyo, Japan, 141-8625
    - NTT Medical Center Tokyo /ID# 225595
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University Hospital /ID# 203630
- Wakayama
  - Wakayama, Wakayama, Japan, 640-8558
    - Japanese Red Cross Wakayama Medical Center /ID# 171196
  - Wakayama, Wakayama, Japan, 641-8510
    - Wakayama Medical University Hospital /ID# 169485
- Yamagata
  - Yamagata, Yamagata, Japan, 990-9585
    - Yamagata University Hospital /ID# 171481
- Yamaguchi
  - Shunan-shi, Yamaguchi, Japan, 745-8522
    - Tokuyama Central Hospital /ID# 226857
Latvia
- - Riga, Latvia, 1035
    - VCA Polyclinic Aura /ID# 160204
  - Riga, Latvia, LV-1002
    - Pauls Stradins Clinical University Hospital /ID# 160205
Lithuania
- - Kaunas, Lithuania, 50161
    - Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 201142
  - Vilnius, Lithuania, 08661
    - Vilnius University Hospital Santaros Klinikos /ID# 201144
Mexico
- - Del. Benito Juárez, Mexico, 03810
    - Health Pharma Professional Research S.A de C.V /ID# 206516
- Morelos
  - Cuernavaca, Morelos, Mexico, 62290
    - JM Research SC /ID# 206518
- Yucatán
  - Mérida, Yucatán, Mexico, 97000
    - Unidad de Atencion Medica e Investigacion en Salud /ID# 206515
Netherlands
- North Brabant
  - Tilburg, North Brabant, Netherlands, 5022 GC
    - Elisabeth Tweesteden Ziekenhuis /ID# 163738
- North Holland
  - Amsterdam, North Holland, Netherlands, 1105 AZ
    - Amsterdam UMC, locatie AMC /ID# 157965
New Zealand
- Bay of Plenty
  - Tauranga South, Bay of Plenty, New Zealand, 3112
    - Tauranga Hospital /ID# 212793
- Canterbury
  - Christchurch, Canterbury, New Zealand, 8011
    - Christchurch Hospital. /ID# 205337
- Otago
  - Otago, Otago, New Zealand, 9016
    - Dunedin Hospital /ID# 212791
- Waikato Region
  - Hamilton, Waikato Region, New Zealand, 3240
    - Waikato Hospital /ID# 212788
- Wellington Region
  - Lower Hutt, Wellington Region, New Zealand, 5010
    - Hutt Hospital /ID# 212787
  - Newtown, Wellington Region, New Zealand, 6021
    - Wellington Regional Hospital /ID# 205338
Poland
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
    - Vitamed Galaj i Cichomski Sp.j. /ID# 213358
  - Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
    - Gastromed Sp. z o.o /ID# 231065
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-363
    - Centrum Medyczne Plejady /ID# 170635
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
    - Vistamed /ID# 210106
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 00-189
    - Centrum Zdrowia MDM /ID# 170283
  - Warsaw, Masovian Voivodeship, Poland, 00-728
    - Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 216103
  - Warsaw, Masovian Voivodeship, Poland, 02-507
    - Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170286
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie Panstwowy Instytut Bada /ID# 170285
  - Warsaw, Masovian Voivodeship, Poland, 03-580
    - Vivamed Sp. z o.o. /ID# 216308
- Pomeranian Voivodeship
  - Sopot, Pomeranian Voivodeship, Poland, 81-756
    - Endoskopia Sp. z o.o. /ID# 170284
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-659
    - NZOZ All-Medicus /ID# 170282
  - Tychy, Silesian Voivodeship, Poland, 43-100
    - H-T Centrum Medyczne Endoterapia /ID# 231501
Portugal
- - Coimbra, Portugal, 3000-075
    - Unidade Local de Saude de Coimbra, EPE /ID# 166050
  - Lisbon, Portugal, 1169-050
    - Duplicate_Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Cap /ID# 165578
  - Porto, Portugal, 4200-319
    - Unidade Local de Saude Sao Joao, EPE /ID# 165577
  - Viseu, Portugal, 3504-509
    - Centro Hosp de Tondela-Viseu /ID# 166049
- Braga District
  - Guimarães, Braga District, Portugal, 4839-008
    - Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 165576
- Faro District
  - Portimão, Faro District, Portugal, 8500-338
    - Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166563
- Porto District
  - Santa Maria DA Feira, Porto District, Portugal, 4520-211
    - Centro Hospitalar de Entre Douro e Vouga /ID# 166048
- Setúbal District
  - Almada, Setúbal District, Portugal, 2805-267
    - Duplicate_Hospital Garcia de Orta, EPE /ID# 165579
Puerto Rico
- - Ponce, Puerto Rico, 00716-0377
    - Ponce Medical School Foundation /ID# 222825
  - San Juan, Puerto Rico, 00921-3201
    - VA Caribbean Healthcare System /ID# 222779
Romania
- - Bucharest, Romania, 011025
    - Sana Monitoring /Id# 224154
  - Bucharest, Romania, 022328
    - Fundeni Clinical Institute /ID# 171259
  - Bucharest, Romania, 022328
    - Fundeni Clinical Institute /ID# 224155
  - Timișoara, Romania, 300002
    - Cabinet Particular Policlinic Algomed /ID# 171260
  - Timișoara, Romania, 300168
    - Duplicate_Centrul Medical Tuculanu SRL /ID# 171263
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400380
    - Clinica Gastro Med SRL /ID# 224156
Russia
- - Dzerzhinskiy, Russia, 140091
    - Clinic of New Technologies of Medicine /ID# 204926
  - Moscow, Russia, 119992
    - First Moscow State Medical University n.a I.M. Sechenov /ID# 204981
  - Moscow, Russia, 123423
    - National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203513
  - Moscow, Russia, 129128
    - Central Clinical Hospital RZHD Medicine /ID# 204922
  - Pushkin, Russia, 196603
    - Euromedservice /ID# 204918
  - Saint Petersburg, Russia, 191186
    - International Medical Center SOGAZ /ID# 206832
  - Ulyanovsk, Russia, 432017
    - Ulyanovsk Regional Clinical Hospital /ID# 204923
- Kabardino-Balkarskaya Respublika
  - Anzorey, Kabardino-Balkarskaya Respublika, Russia, 361350
    - Interdisctrict Multidisciplinary Hospital /ID# 204921
  - Nal'chik, Kabardino-Balkarskaya Respublika, Russia, 360001
    - GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233974
- Kaliningrad Oblast
  - Kaliningrad, Kaliningrad Oblast, Russia, 236016
    - Immanuel Kant Baltic Federal University /ID# 204920
- Kemerovo Oblast
  - Kemerovo, Kemerovo Oblast, Russia, 650099
    - Kuzbass Regional Clinical Hospital /ID# 165759
- Leningradskaya Oblast'
  - Saint Petersburg, Leningradskaya Oblast', Russia, 198218
    - Uninova Medical Center /ID# 229786
- Moscow Oblast
  - Korolyov, Moscow Oblast, Russia, 141077
    - Arsvita Clinic /ID# 208947
- Novosibirsk Oblast
  - Novosibirsk, Novosibirsk Oblast, Russia, 630007
    - Novosibirski Gastrocenter /ID# 229852
- Permskiy Kray
  - Perm, Permskiy Kray, Russia, 614109
    - Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227456
- Sankt-Peterburg
  - Sestroretsk, Sankt-Peterburg, Russia, 197706
    - City Clinical Hospital #40 /ID# 204927
- Tyumen Oblast
  - Tyumen, Tyumen Oblast, Russia, 625023
    - Regional Clinical Hospital #1 /ID# 165763
Serbia
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Clinical Hosp Center Zvezdara /ID# 200150
  - Belgrade, Beograd, Serbia, 11000
    - University Clinical Center Serbia /ID# 200153
  - Belgrade, Beograd, Serbia, 11080
    - Clin Hosp Ctr Bezanijska Kosa /ID# 202060
  - Belgrade, Beograd, Serbia, 11040
    - Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224927
- Jablanicki Okrug
  - Leskovac, Jablanicki Okrug, Serbia, 16000
    - General Hospital Leskovac /ID# 224198
- Vojvodina
  - Novi Sad, Vojvodina, Serbia, 21000
    - Duplicate_Clinical Center Vojvodina /ID# 156876
Singapore
- Central Singapore
  - Singapore, Central Singapore, Singapore, 228510
    - Mount Elizabeth Hospital /ID# 206563
Slovakia
- Banská Bystrica Region
  - Banská Bystrica, Banská Bystrica Region, Slovakia, 975 17
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164348
- Nitra Region
  - Nitra, Nitra Region, Slovakia, 949 01
    - KM Management, spol. s.r.o. /ID# 206603
  - Nové Zámky, Nitra Region, Slovakia, 940 34
    - Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224100
- Presov
  - Prešov, Presov, Slovakia, 080 01
    - Gastro I., s.r.o. /ID# 164345
Slovenia
- - Ljubljana, Slovenia, 1000
    - Univ Medical Ctr Ljubljana /ID# 210628
South Africa
- Free State
  - Bloemfontein, Free State, South Africa, 9301
    - Farmovs (Pty) Ltd /Id# 207538
- Gauteng
  - Johannesburg, Gauteng, South Africa, 1619
    - Clinresco Centers /ID# 239825
- Western Cape
  - CAPE TOWN Milnerton, Western Cape, South Africa, 7441
    - Spoke Research Inc /ID# 229906
  - Cape Town, Western Cape, South Africa, 7700
    - Allergy & Immunology (AIU) /ID# 171439
  - Cape Town, Western Cape, South Africa, 7708
    - Dr JP Wright /ID# 171142
  - Cape Town, Western Cape, South Africa, 7800
    - Private Practice Dr MN Rajabally /ID# 171141
South Korea
- - Daegu, South Korea, 42415
    - Yeungnam University Medical Center /ID# 158662
  - Seoul, South Korea, 03722
    - Yonsei University Health System Severance Hospital /ID# 158660
- Busan Gwang Yeogsi
  - Busan, Busan Gwang Yeogsi, South Korea, 48108
    - Inje University Haeundae Hospital /ID# 203027
  - Busan, Busan Gwang Yeogsi, South Korea, 49201
    - Dong-A University Medical Center /ID# 158665
  - Busan, Busan Gwang Yeogsi, South Korea, 49241
    - Duplicate_Pusan National University Hospital /ID# 158670
- Daejeon Gwang Yeogsi
  - Daejeon, Daejeon Gwang Yeogsi, South Korea, 34943
    - The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 242379
- Gyeonggido
  - Guri-si, Gyeonggido, South Korea, 11923
    - Duplicate_Hanyang University Gurihospital /ID# 158661
  - Seongnam, Gyeonggido, South Korea, 13496
    - CHA Bundang Medical Center /ID# 158669
  - Suwon, Gyeonggido, South Korea, 16247
    - The Catholic University Of Korea St. Vincent's Hospital /ID# 158664
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03181
    - Kangbuk Samsung Hospital /ID# 158666
  - Seoul, Seoul Teugbyeolsi, South Korea, 06351
    - Samsung Medical Center /ID# 158663
Spain
- - Barcelona, Spain, 08036
    - Hospital Clinic de Barcelona /ID# 159462
  - Córdoba, Spain, 14004
    - Duplicate_Hospital Universitario Reina Sofia /ID# 167062
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz /ID# 159471
  - Pontevedra, Spain, 36071
    - Complejo Hospitalario Universitario de Pontevedra /ID# 216183
  - Salamanca, Spain, 37711
    - Hospital Universitario de Salamanca /ID# 159469
  - Seville, Spain, 41009
    - Hospital Universitario Virgen Macarena /ID# 159969
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet /ID# 159468
- A Coruna
  - Ferrol, A Coruna, Spain, 15405
    - Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159463
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159473
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Majadahonda /ID# 159466
- Pontevedra
  - Vigo, Pontevedra, Spain, 36213
    - Hospital Alvaro Cunqueiro CHUVI /ID# 167359
- Principality of Asturias
  - Gijón, Principality of Asturias, Spain, 33394
    - Hospital Universitario de Cabuenes /ID# 170745
Sweden
- - Stockholm, Sweden, 182 88
    - Danderyds sjukhus AB /ID# 202036
- Västra Götaland County
  - Alingsås, Västra Götaland County, Sweden, 441 33
    - Alingsas lasarett /ID# 202075
  - Mölndal, Västra Götaland County, Sweden, 431 80
    - Sahlgrenska University Hospital Molndal /ID# 202841
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital, Universitaetsspital Bern /ID# 202909
- Canton of Zurich
  - Zurich, Canton of Zurich, Switzerland, 8091
    - University Hospital Zurich /ID# 202908
Taiwan
- - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital /ID# 171433
  - Taichung, Taiwan, 40447
    - China Medical University Hospital /ID# 160194
  - Taichung, Taiwan, 402
    - Chung Shan Medical University Hospital /ID# 171426
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hosp /ID# 171436
  - Taoyuan, Taiwan, 333
    - Linkou Chang Gung Memorial Hospital /ID# 222878
- Taipei
  - Taipei City, Taipei, Taiwan, 100
    - National Taiwan University Hospital /ID# 162188
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06590
    - Ankara Univ Medical Faculty /ID# 167205
  - Battalgazi/malatya, Turkey (Türkiye), 44280
    - Inonu Universitesi Turgut Ozal /ID# 203980
  - Bursa, Turkey (Türkiye), 16059
    - Uludag University Medical Faculty /ID# 204179
  - Elâzığ, Turkey (Türkiye), 23100
    - F?rat University Medical Facul /ID# 171285
  - Istanbul, Turkey (Türkiye), 34098
    - Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 167202
  - Istanbul, Turkey (Türkiye), 34899
    - Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171290
- Istanbul
  - Kadıköy, Istanbul, Turkey (Türkiye), 34742
    - Acibadem Kozyatagi Hospital /ID# 213277
  - Şişli, Istanbul, Turkey (Türkiye), 34371
    - Sisli Etfal Train & Res Hosp /ID# 171415
- Kayseri
  - Melikgazi, Kayseri, Turkey (Türkiye), 38030
    - Duplicate_Erciyes University Medical Fac /ID# 171283
Ukraine
- - Ivano-Frankivsk, Ukraine, 76018
    - CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203366
  - Kherson, Ukraine, 73000
    - Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224349
  - Kyiv, Ukraine, 04073
    - CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224344
  - Kyiv, Ukraine, 02091
    - Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 205484
  - Kyiv, Ukraine, 04116
    - Medical center of the private enterprise Sygma /ID# 224347
United Kingdom
- - Barnsley, United Kingdom, S75 2EP
    - Barnsley Hospital NHS Foundation Trust /ID# 202771
  - Liverpool, United Kingdom, L7 8XP
    - Liverpool University Hospitals NHS Foundation Trust /ID# 203860
  - Newcastle upon Tyne, United Kingdom, NE3 3HD
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158047
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
    - Addenbrookes Hospital /ID# 158046
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Royal Devon & Exeter Hospital /ID# 157614
- Edinburgh, City of
  - Edinburgh, Edinburgh, City of, United Kingdom, EH4 2XU
    - Western General Hospital - NHS Lothian /ID# 208801
- Greater London
  - London, Greater London, United Kingdom, E1 2ES
    - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 157617
  - London, Greater London, United Kingdom, SE5 9RS
    - Kings College Hospital NHS Foundation Trust /ID# 158762
  - London, Greater London, United Kingdom, SW17 0QT
    - St George University Hospitals NHS Foundation Trust /ID# 208379
- Hampshire
  - Southampton, Hampshire, United Kingdom, SO16 6YD
    - University Hospital Southampton NHS Foundation Trust /ID# 210814
United States
- California
  - Coronado, California, United States, 92118-1408
    - Southern California Res. Ctr. /ID# 169659
  - Irvine, California, United States, 92618
    - Hoag Memorial Hosp Presbyterian /ID# 218347
  - La Jolla, California, United States, 92037
    - UC San Diego Health System /ID# 160430
  - Los Alamitos, California, United States, 90720-3309
    - United Medical Doctors /ID# 158574
  - Los Angeles, California, United States, 90067-2001
    - Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center /ID# 163848
  - San Francisco, California, United States, 94115
    - UCSF Medical Center - Mount Zion /ID# 201209
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Peak Gastroenterology Associates, PC /ID# 165838
  - Lone Tree, Colorado, United States, 80124-6798
    - Rocky Mountain Pediatric Gastroenterology /ID# 207173
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - Duplicate_Medical Research Center of CT /ID# 160287
  - New Haven, Connecticut, United States, 06510
    - Yale Univ Digestive Diseases /ID# 213265
- Florida
  - Clermont, Florida, United States, 34711
    - South Lake Pain Institute, Inc /ID# 162859
  - Maitland, Florida, United States, 32751-6108
    - Ctr for Advanced Gastroenterol /ID# 202820
  - Miami, Florida, United States, 33136
    - University of Miami /ID# 160456
  - Miami, Florida, United States, 33186-4643
    - Coral Research Clinic /ID# 158608
  - Miami, Florida, United States, 33193
    - South Florida Research Ph I-IV, Inc. /ID# 161844
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Naples /ID# 165210
  - New Port Richey, Florida, United States, 34653
    - Advanced Research Institute, Inc /ID# 161945
  - Orlando, Florida, United States, 32803
    - Advent Health /ID# 160393
  - Orlando, Florida, United States, 32803
    - Endoscopic Research, Inc. /ID# 206709
  - Orlando, Florida, United States, 32808
    - Omega Research Group /ID# 203105
  - Sweetwater, Florida, United States, 33172
    - Duplicate_Lenus Research & Medical Group /ID# 169727
  - Tampa, Florida, United States, 33607
    - Clinical Research Trials of Florida, Inc. /ID# 201794
  - Tampa, Florida, United States, 33613-4680
    - Duplicate_AdventHealth Tampa /ID# 170482
- Georgia
  - Macon, Georgia, United States, 31201
    - Gastroenterology Associates of Central Georgia, LLC /ID# 160513
- Illinois
  - Chicago, Illinois, United States, 60637-1443
    - The University of Chicago Medical Center /ID# 160511
  - Oak Lawn, Illinois, United States, 60453
    - DM Clinical Research/Southwest /ID# 165009
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University /ID# 167250
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Univ Kansas Med Ctr /ID# 226601
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Clinical Research Center, Digestive Health /ID# 160367
- Kentucky
  - Louisville, Kentucky, United States, 40206
    - Duplicate_Robley Rex VA Medical Center /ID# 218647
- Louisiana
  - Houma, Louisiana, United States, 70360
    - Houma Digestive Health Special /ID# 158377
  - New Orleans, Louisiana, United States, 70115
    - Delricht Research /ID# 206817
  - New Orleans, Louisiana, United States, 70115
    - Nola Research Works, LLC /ID# 161356
  - Shreveport, Louisiana, United States, 71105-6800
    - Louisiana Research Center, LLC /ID# 201205
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164257
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 159430
  - Chesterfield, Michigan, United States, 48047
    - Clin Res Inst of Michigan, LLC /ID# 160300
- Minnesota
  - Rochester, Minnesota, United States, 55905-0001
    - Mayo Clinic - Rochester /ID# 200455
- Nebraska
  - Omaha, Nebraska, United States, 68114-3723
    - Quality Clinical Research Inc. /ID# 167312
- New York
  - New York, New York, United States, 10022
    - Weill Cornell Medicine /ID# 165884
  - New York, New York, United States, 10032-3725
    - Columbia Univ Medical Center /ID# 161929
  - New York, New York, United States, 10075
    - Lenox Hill Hospital /ID# 168469
  - New York, New York, United States, 10279
    - Manhattan Clinical Research, LLC /ID# 211803
  - North Massapequa, New York, United States, 11758
    - Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171128
  - Rochester, New York, United States, 14642
    - Duplicate_University of Rochester Medical Center /ID# 161660
- North Carolina
  - Charlotte, North Carolina, United States, 28203
    - Atrium Health Carolinas Medical Center /ID# 158543
- North Dakota
  - Fargo, North Dakota, United States, 58104-5925
    - Plains Clinical Research Center, LLC /ID# 169729
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Main Campus /ID# 209235
  - Columbus, Ohio, United States, 43210
    - The Ohio State University /ID# 164713
  - Columbus, Ohio, United States, 43235
    - Optimed Research, Ltd. /ID# 167112
  - Mentor, Ohio, United States, 44060-6211
    - Great Lakes Gastroenterology Research, LLC /ID# 201778
  - Sylvania, Ohio, United States, 43560-2767
    - ProMedica Physicians Digestive Healthcare /ID# 215622
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists /ID# 170777
  - Tulsa, Oklahoma, United States, 74136-7823
    - Adult Gastroenterology Associates - Gen 1 Research /ID# 208873
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033-2360
    - Penn State Milton S. Hershey Medical Center /ID# 230474
  - Philadelphia, Pennsylvania, United States, 19104-5502
    - University of Pennsylvania /ID# 166262
  - Wyomissing, Pennsylvania, United States, 19610
    - Digestive Disease Associates, LTD - Wyomissing /ID# 232406
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Gastroenterology Associates, P.A. of Greenville /ID# 160457
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - Gastro One /ID# 160373
  - Johnson City, Tennessee, United States, 37604
    - Duplicate_East Tennessee Research Institute /ID# 168744
  - Nashville, Tennessee, United States, 37232-0011
    - Vanderbilt University Medical Center /ID# 160567
- Texas
  - Baytown, Texas, United States, 77521-2415
    - Inquest Clinical Research /ID# 165686
  - Cedar Park, Texas, United States, 78613-5028
    - Texas Digestive Disease Consultants /ID# 209951
  - Cedar Park, Texas, United States, 78613
    - GI Alliance /ID# 209799
  - Garland, Texas, United States, 75044
    - Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 158235
  - Houston, Texas, United States, 77017-2337
    - Vilo Research Group Inc /ID# 207657
  - Houston, Texas, United States, 77058
    - Centex Studies, Inc. - Houston /ID# 201221
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine /ID# 158230
  - Lubbock, Texas, United States, 79424-3017
    - Duplicate_Caprock Gastro Research, LLC /ID# 215433
  - San Antonio, Texas, United States, 78212
    - Clinical Associates in Research Therapeutics of America, LLC /ID# 161364
  - San Antonio, Texas, United States, 78229-5390
    - Southern Star Research Institute, LLC /ID# 168774
  - Temple, Texas, United States, 76508
    - Baylor Scott & White Center for Diagnostic Medicine /ID# 204132
  - Tyler, Texas, United States, 75701
    - Tyler Research Institute, LLC /ID# 166799
  - Victoria, Texas, United States, 77904
    - Gastro Health & Nutrition - Victoria /ID# 164308
- Utah
  - Ogden, Utah, United States, 84405
    - Advanced Research Institute /ID# 160465
- Virginia
  - Roanoke, Virginia, United States, 24014-1372
    - Gastroenterology Consultants of Southwest Virginia /ID# 218142
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason Hospital & Medical Center /ID# 160432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria:

Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Substudy 1: Double-blind Placebo Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.	Drug: placebo for risankizumab subcutaneous (SC) injection
Experimental: Substudy 1: Double-blind Risankizumab Dose 1 Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Substudy 1: Double-blind Risankizumab Dose 2 Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Substudy 2: Open-label (OL) Clinical Assessment Risankizumab Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Substudy 3: OL Extension Risankizumab Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: OL Continuous Treatment Extension - Dose 1 Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: OL Continuous Treatment Extension - Dose 2 Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.	Drug: risankizumab subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI

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 Time Frame: Week 52	Clinical remission per Adapted Mayo Score.	Week 52
Percentage of Participants with Adverse Events (AE) Time Frame: Up to Week 300	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Week 300

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time Frame: Baseline (Week 0) to Week 52	The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.	Baseline (Week 0) to Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 Time Frame: Week 52	Clinical remission per Adapted Mayo Score.	Week 52
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement Time Frame: Week 52	Percentage of participants achieving histologic-endoscopic mucosal improvement.	Week 52
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time Frame: Week 0 to Week 52	The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.	Week 0 to Week 52
Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week Time Frame: Baseline (Week 0) to Week 52	Change in number of fecal incontinence episodes per week.	Baseline (Week 0) to Week 52
Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms Time Frame: Baseline (Week 0) to Week 52	Change in number of days per week with sleep interrupted due to UC symptoms.	Baseline (Week 0) to Week 52
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement Time Frame: Week 52	Endoscopic improvement per endoscopy subscore.	Week 52
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission Time Frame: Week 52	Endoscopic remission per endoscopy subscore.	Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days Time Frame: Week 52	Clinical remission per Adapted Mayo Score.	Week 52
Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency Time Frame: Week 52	Percentage of participants achieving no bowel urgency.	Week 52
Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain Time Frame: Week 52	Percentage of participants achieving no abdominal pain.	Week 52
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission Time Frame: Week 52	Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.	Week 52
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 Time Frame: Week 52	Endoscopic improvement per endoscopy subscore.	Week 52
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score Time Frame: Week 52	Clinical response per Adapted Mayo Score.	Week 52
Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements Time Frame: Week 52	Percentage of participants achieving no nocturnal bowel movements.	Week 52
Sub-Study 1: Percentage of Participants Achieving No Tenesmus Time Frame: Week 52	Percentage of participants achieving no tenesmus.	Week 52
Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization Time Frame: Through Week 52	Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.	Through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Related Info.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

February 1, 2029

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)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M16-066
2023-506994-36-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Ulcerative Colitis (UC)

Clinical Trials on placebo for risankizumab

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