A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

May 19, 2022 updated by: AbbVie

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

618

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

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
      • Cordoba, Argentina, 5016
        • Hospital Privado Univesitario /ID# 168080
    • Ciuadad Autonoma De Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1280
        • Hospital Britanico de Buenos Aires /ID# 168081
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431
        • Cemic /Id# 168082
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Hospital Provincial del Centenario /ID# 170904
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited /ID# 167216
      • Southport, Queensland, Australia, 4222
        • Griffith University /ID# 212631
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital /ID# 211364
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 213510
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital /ID# 211362
  • Austria
    • Niederoesterreich
      • Sankt Poelten, Niederoesterreich, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 166423
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Duplicate_LKH-Univ. Klinikum Graz /ID# 158134
    • Wien
      • Vienna, Wien, Austria, 1020
        • Krankenhaus der Barmherzigen Brueder Wien /ID# 211418
      • Vienna, Wien, Austria, 1090
        • Duplicate_Medical University of Vienna /ID# 158135
  • Belarus
      • Витебск, Belarus, 210001
        • Vitebsk Regional Advanced Clin /ID# 204807
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis /ID# 157381
      • Gent, Belgium, 9000
        • AZ Maria Middelares /ID# 212871
      • Kortrijk, Belgium, 8500
        • AZ Groeninge /ID# 212571
      • Merksem, Belgium, 2170
        • ZNA - Jan Palfijn /ID# 212822
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • AZ Sint-Maarten /ID# 212280
    • Bruxelles-Capitale
      • Brussels, Bruxelles-Capitale, Belgium, 1070
        • ULB Hospital Erasme /ID# 157386
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 157384
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 157383
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 165132
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 157710
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 165018
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT Dr Georgi Stranski EAD /ID# 203975
      • Plovdiv, Bulgaria, 4001
        • University Multiprofile Hospit /ID# 165697
      • Sofia, Bulgaria, 1202
        • Second Multiprofile Hospital f /ID# 165699
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic UMHAT Tokuda /ID# 165698
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski /ID# 204713
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Joanna - ISUL /ID# 211241
      • Stara Zagora, Bulgaria, 6004
        • MHAT Trakia /ID# 201665
      • Varna, Bulgaria, 9010
        • University Multiprofile Hospit /ID# 167576
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary - Heritage Medical Research Clinic /ID# 157156
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 169766
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta - Zeidler Ledcor Centre /ID# 157100
      • Edmonton, Alberta, Canada, T6K 4B2
        • Covenant Health /ID# 161636
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc /ID# 159057
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 157097
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 161635
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII - Health Sciences Centre /ID# 157089
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Center /ID# 165909
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center /ID# 157162
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation /ID# 165910
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicor Research Inc /ID# 157151
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Asso /ID# 157159
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie /ID# 161634
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Center /ID# 157086
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 210758
      • Talcahuano, Chile, 1740000
        • Hospital Las Higueras /ID# 167091
    • Region Metropolitana De Santiago
      • Santiago, Region Metropolitana De Santiago, Chile, 8207257
        • Complejo Asistencial Dr. Sotero del Rio /ID# 169383
      • Santiago, Region Metropolitana De Santiago, Chile, 8350488
        • Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 2540488
        • Centro de Investigaciones Clínicas Viña del Mar /ID# 203585
  • China
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University /ID# 210888
      • Pudong New District, China, 200136
        • Shanghai East Hospital /ID# 212671
      • Tianjin, China, 300052
        • Duplicate_Tianjin Med Univ General Hosp /ID# 210925
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hosp Sun /ID# 210783
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857
      • Wuhan, Hubei, China, 430022
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 211035
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310020
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050024
        • Instituto de Coloproctologia /ID# 158740
      • Medellín, Antioquia, Colombia, 50034
        • Hospital Pablo Tobon Uribe /ID# 158732
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110231
        • Hospital Univ San Ignacio /ID# 158737
  • Croatia
      • Zadar, Croatia, 23000
        • Zadar General Hospital /ID# 157706
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre milosrdnice /ID# 157720
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 157703
    • Osjecko-baranjska Zupanija
      • Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
        • UHC Osijek /ID# 157704
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinicki bolnicki centar Split /ID# 157705
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 163218
      • Olomouc, Czechia, 779 00
        • CTCenter MaVe s.r.o. /ID# 163215
      • Pardubice, Czechia, 530 03
        • Nemocnice Pardubickeho kraje, a.s. /ID# 163219
      • Praha, Czechia, 118 33
        • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304
      • Praha, Czechia, 140 00
        • Axon Clinical, s.r.o. /ID# 163216
      • Praha, Czechia, 140 59
        • Thomayerova nemocnice /ID# 162942
      • Praha, Czechia, 143 00
        • ResTrial s.r.o. /ID# 211074
      • Praha, Czechia, 155 00
        • NH Hospital a.s. /ID# 211073
    • Praha 4
      • Prague 4, Praha 4, Czechia, 140 00
        • Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitets Hospital /ID# 160685
      • Odense C, Denmark, 5000
        • Odense Universitets Hospital /ID# 155536
    • Hovedstaden
      • Hvidovre, Hovedstaden, Denmark, 2650
        • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535
    • Midtjylland
      • Aarhus N, Midtjylland, Denmark, 8200
        • Aarhus University Hospital /ID# 155534
    • Sjælland
      • Roskilde, Sjælland, Denmark, 4000
        • Sjællands Universitetshospital, Roskilde /ID# 155537
    • Syddanmark
      • Nyborg, Syddanmark, Denmark, 5800
        • Sygehusenheden Nyborg - OUH /ID# 161591
  • Egypt
      • Al Sharqia, Egypt, 44519
        • Zagazig University Hospitals /ID# 164018
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423
      • Cairo, Egypt, 11559
        • Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176
      • Cairo, Egypt, 11559
        • National Hepatology and Tropical Medicine Research Institute /ID# 157875
      • Cairo, Egypt, 11566
        • Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630
  • Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital /ID# 157073
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 10138
        • East Tallinn Central Hospital /ID# 157072
  • France
      • La Tronche, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 211980
      • Rennes, France, 35033
        • Hospital Pontchaillou /ID# 213207
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital L'Archet Ii /Id# 162545
    • Auvergne-Rhone-Alpes
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • HCL - Hôpital Lyon Sud /ID# 162548
    • Gironde
      • Pessac CEDEX, Gironde, France, 33604
        • CHU Bordeaux - Hopital Haut Lévêque /ID# 162546
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 162547
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hôpital Saint Eloi /ID# 215146
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hapital Beaujon /ID# 166287
    • Loire
      • St. Priest En Jarez, Loire, France, 42270
        • CHU de SAINT ETIENNE - Hopital Nord /ID# 162550
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • CHRU Nancy - Hôpitaux de Brabois /ID# 162549
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 165056
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892
      • Berlin, Germany, 10787
        • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976
      • Berlin, Germany, 10825
        • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend /ID# 166149
      • Berlin-Zehlendorf, Germany, 14163
        • Krankenhaus Waldfriede /ID# 212729
      • Braunschweig, Germany, 38126
        • Stadtisches Klinikum Braunschweig /ID# 163673
      • Dachau, Germany, 85221
        • Medizinisches Versorgunszentrum Dachau /ID# 211550
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus /ID# 159334
      • Freiburg, Germany, 79106
        • Duplicate_Universitaetsklinikum Freiburg /ID# 162025
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg /ID# 159336
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 162027
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH /ID# 212077
      • Lueneburg, Germany, 21339
        • Klinikum Lueneburg /ID# 163671
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg /ID# 211840
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024
      • Regensburg, Germany, 93042
        • Universitaetsklinikum Regensburg /ID# 163812
      • Wiesbaden, Germany, 65189
        • Duplicate_Gastro-Praxis Wiesbaden /ID# 159335
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69121
        • Praxis fuer Gastroenterologie /ID# 166148
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 162026
      • Tübingen, Baden-Wuerttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen /ID# 159341
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 164988
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 159332
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 212977
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 51103
        • Evangelisches Krankenhaus Kalk /ID# 212724
      • Grevenbroich, Nordrhein-Westfalen, Germany, 41515
        • Praxiszentrum fuer Gastroenterologie /ID# 211965
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln /ID# 164987
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 159333
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 157415
      • Pireaus, Greece, 18454
        • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419
      • Thessaloniki, Greece, 54639
        • Theageneio Anticancer Hospital /ID# 163922
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905
      • Piraeus, Attiki, Greece, 18536
        • Tzaneio general hospital of Piraeus /ID# 206441
    • Kriti
      • Heraklion, Kriti, Greece, 71307
        • University General Hospital of Heraklion PA.G.N.I /ID# 157417
  • Ireland
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 157570
    • Dublin
      • Beaumont, Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 157572
      • Elm Park, Dublin, Ireland, D04 T6F4
        • St Vincent's University Hospital /ID# 157569
  • Israel
      • Haifa, Israel, 3109601
        • Duplicate_Rambam Medical Center /ID# 171056
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 163539
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 171055
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 171062
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 157789
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5239424
        • Sheba Medical Center /ID# 171059
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 157787
  • Italy
      • Bologna, Italy, 40138
        • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659
      • Catania, Italy, 95126
        • A.O. Per L'Emergenza Cannizzaro /ID# 161303
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657
      • Milano, Italy, 20157
        • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655
      • Pavia, Italy, 27100
        • Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030
    • Ancona
      • Torrette, Ancona, Italy, 60123
        • Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
        • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433
      • Rome, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 155660
      • Rome, Lazio, Italy, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434
    • Milano
      • Rho, Milano, Italy, 20017
        • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 155658
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 158023
      • Rome, Roma, Italy, 00168
        • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656
    • Toscana
      • Florence, Toscana, Italy, 50139
        • Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Hospital /ID# 202516
      • Busan, Korea, Republic of, 49201
        • Duplicate_Dong-A University Hospital /ID# 163370
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 163376
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center /ID# 163366
      • Daejeon, Korea, Republic of, 34943
        • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 163426
    • Gyeonggido
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Hanyang University Guri Hospital /ID# 163351
      • Seongnam si, Gyeonggido, Korea, Republic of, 13496
        • CHA Bundang Medical center CHA University /ID# 163377
      • Suwon, Gyeonggido, Korea, Republic of, 16247
        • The Catholic University of Korea, ST. Vincent's Hospital /ID# 163365
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 163354
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Severance Hospital /ID# 163374
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital /ID# 159616
      • Riga, Latvia, LV-1079
        • Riga East Clinical University Hospital /ID# 159615
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584
      • Vilnius, Lithuania, 08661
        • Vinius University Hospital Santaros Klinikos /ID# 162524
  • Malaysia
      • Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia /ID# 160661
    • Sabah
      • Division Pantai Barat Utara, Sabah, Malaysia, 88200
        • Queen Elizabeth Hospital /ID# 160659
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 56000
        • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362
  • Mexico
      • Del. Benito Juárez, Mexico, 03810
        • Health Pharma Professional Research S.A de C.V /ID# 170763
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • JM Research SC /ID# 170762
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Unidad de Atencion Medica e Investigacion en Salud /ID# 170765
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 157953
      • Tilburg, Netherlands, 5022 GC
        • Elisabeth Tweesteden Ziekenhuis /ID# 163620
  • New Zealand
      • Auckland, New Zealand, 2025
        • Middlemore Clinical Trials /ID# 167214
      • Wellington, New Zealand, 6021
        • Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Christchurch Hospital /ID# 167212
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Dunedin Hospital /ID# 167215
  • Poland
      • Warsaw, Poland, 03-580
        • Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 52-210
        • Planetmed Sp. z o.o. /ID# 205159
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-049
        • 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984
      • Lublin, Lubelskie, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 163602
      • Warszawa, Mazowieckie, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604
      • Warszawa, Mazowieckie, Poland, 04-730
        • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-326
        • Centrum Medyczne Medyk /ID# 212888
    • Pomorskie
      • Chojnice, Pomorskie, Poland, 89-600
        • Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079
    • Slaskie
      • Tychy, Slaskie, Poland, 43-100
        • H-T. Centrum Medyczne - Endoterapia /ID# 212458
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-561
        • Wojewodzki Szpital Specjalistyczny /ID# 212400
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta, EPE /ID# 160688
      • Faro, Portugal, 8000-386
        • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732
      • Lisboa, Portugal, 1169-050
        • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677
      • Lisboa, Portugal, 1349-019
        • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Ângelo /ID# 207758
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742
      • Viseu, Portugal, 3504-509
        • Centro Hosp de Tondela-Viseu /ID# 160731
    • Braga
      • Guimaraes, Braga, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691
    • Faro
      • Portimão, Faro, Portugal, 8500-338
        • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754
    • Porto
      • Santa Maria Da Feira, Porto, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga /ID# 160676
  • Romania
      • Bucharest, Romania, 022328
        • Duplicate_Institutul Clinic Fundeni /ID# 170888
      • Cluj, Romania, 400132
        • Tvm Med Serv Srl /Id# 170891
      • Timisoara, Romania, 300168
        • Duplicate_Centrul Medical Tuculanu SRL /ID# 170892
      • Timișoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed /ID# 170889
    • Bucuresti
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 170890
  • Russian Federation
      • Moscow, Russian Federation, 123423
        • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital No. 31 /ID# 208865
      • Ulyanovsk, Russian Federation, 432017
        • Ulyanovsk Regional Clinical Hospital /ID# 200700
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650099
        • Kuzbass Regional Clinical Hospital /ID# 200707
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614990
        • Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438
    • Stavropol Skiy Kray
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
        • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701
    • Tverskaya Oblast
      • Tver, Tverskaya Oblast, Russian Federation, 170036
        • Tver Regional Clinical Hospital /ID# 206586
    • Tyumenskaya Oblast
      • Tyumen, Tyumenskaya Oblast, Russian Federation, 625023
        • Regional Clinical Hospital #1 /ID# 200708
    • Udmurtskaya Respublika
      • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
        • Alliance Biomedical Ural Group /ID# 200703
  • Serbia
      • Belgrade, Serbia, 11000
        • University Children's Hospital 'Tirsova' /ID# 211480
      • Belgrade, Serbia, 11040
        • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 156956
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 156963
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 156957
      • Belgrade, Beograd, Serbia, 11080
        • Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 156961
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clinical Center Vojvodina /ID# 156958
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 160662
      • Singapore, Singapore, 169608
        • Singapore General Hospital /ID# 160663
      • Singapore, Singapore, 228510
        • KL Ling Gastroenterology and Liver Clinic /ID# 205736
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453
      • Martin, Slovakia, 036 01
        • Univerzitna nemocnica Martin /ID# 163205
      • Nitra, Slovakia, 949 01
        • KM Management, spol. s.r.o. /ID# 206762
      • Presov, Slovakia, 080 01
        • GASTRO I., s.r.o. /ID# 156455
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 171169
    • Western Cape
      • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
        • Spoke Research Inc /ID# 171172
      • Cape Town, Western Cape, South Africa, 7708
        • Kingsbury Hospital /ID# 171158
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice Dr MN Rajabally /ID# 171159
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 157533
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 161144
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 159232
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca /ID# 157539
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 159966
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia /ID# 209699
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 157537
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet /ID# 157538
    • A Coruna
      • Ferrol, A Coruna, Spain, 15405
        • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital Universitario Basurto /ID# 205188
  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitätsspital Basel /ID# 166321
    • Zuerich
      • Zürich, Zuerich, Switzerland, 8091
        • Universitätsspital Zürich /ID# 163528
  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hosp /ID# 160134
      • Taichung City, Taiwan, 40447
        • China Medical University Hosp /ID# 160130
      • Tainan City, Taiwan, 70403
        • National Cheng Kung University Hospital /ID# 160129
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital /ID# 162189
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 212711
  • Ukraine
      • Uzhhorod, Ukraine, 88000
        • Duplicate_Transcarpathian Regional Clin. /ID# 167958
      • Київ, Ukraine, 01030
        • Kyiv Municipal Clinical Hospital #18 /ID# 162527
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
        • Barnsley Hospital NHS Foundation Trust /ID# 202772
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 157577
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust /ID# 158037
      • Edinburgh, United Kingdom, EH3 9HE
        • NHS Lothian /ID# 207446
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust /ID# 158759
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trusts /ID# 158758
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 158039
      • Salford, United Kingdom, M6 8HD
        • Duplicate_Northern Care Alliance NHS Group /ID# 207765
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde /ID# 202314
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System /ID# 162261
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Shea /ID# 165825
      • Tempe, Arizona, United States, 85284-2604
        • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882
      • Tucson, Arizona, United States, 85724
        • University of Arizona /ID# 158305
    • Arkansas
      • Little Rock, Arkansas, United States, 72209-7040
        • Duplicate_Atria Clinical Research /ID# 164504
    • California
      • Coronado, California, United States, 92118-1408
        • Southern California Res. Ctr. /ID# 211989
      • Huntington Beach, California, United States, 92648-5994
        • Newport Huntington Medica /ID# 213034
      • La Jolla, California, United States, 92093
        • UC San Diego Health Systems /ID# 155576
      • Los Alamitos, California, United States, 90720-3309
        • United Medical Doctors /ID# 207887
      • Los Angeles, California, United States, 90048
        • TLC Clinical Research Inc /ID# 212501
      • Los Angeles, California, United States, 90067-2001
        • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655
      • Murrieta, California, United States, 92563
        • United Medical Doctors - Murrieta /ID# 158278
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates, PC /ID# 165832
      • Lone Tree, Colorado, United States, 80124-6798
        • Rocky Mountain Pediatric Gastroenterology /ID# 207171
    • Connecticut
      • Danbury, Connecticut, United States, 06810-6000
        • Western Connecticut Medical Group /ID# 165874
    • Florida
      • Brandon, Florida, United States, 33510
        • Seffner Premier Health Care, PA /ID# 162259
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 205864
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 208127
      • Clermont, Florida, United States, 34711
        • South Lake Pain Institute, Inc /ID# 162798
      • DeBary, Florida, United States, 32713-2260
        • Omega Research Maitland, LLC /ID# 171080
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research /ID# 165426
      • Kissimmee, Florida, United States, 34741-4161
        • SIH Research Mumtaz, Inc /ID# 163081
      • Lighthouse Point, Florida, United States, 33064
        • Alliance Medical Research /ID# 163834
      • Maitland, Florida, United States, 32751-6108
        • Cfagi Llc /Id# 202482
      • Miami, Florida, United States, 33136
        • University of Miami /ID# 155011
      • Miami, Florida, United States, 33176-1032
        • Vista Health Research, LLC /ID# 212828
      • Miami, Florida, United States, 33176
        • ITB Research /ID# 161278
      • Miami, Florida, United States, 33186-4643
        • Coral Research Clinic /ID# 158330
      • Miami, Florida, United States, 33193
        • South Florida Research Ph I-IV, Inc. /ID# 161825
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Naples /ID# 165192
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 161973
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 205903
      • Palmetto Bay, Florida, United States, 33157
        • IMIC Inc. Medical Research /ID# 154944
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 201606
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastro Assoc /ID# 154755
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 154865
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Division of GI/Hepatology /ID# 158250
      • Chicago, Illinois, United States, 60637-1443
        • The University of Chicago Medical Center /ID# 157113
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem /ID# 158254
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology /ID# 164764
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Res Ctr /ID# 154753
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center /ID# 157109
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /ID# 210523
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970
      • Houma, Louisiana, United States, 70360
        • Houma Digestive Health Special /ID# 158253
      • New Orleans, Louisiana, United States, 70115
        • Delricht Research /ID# 206567
      • New Orleans, Louisiana, United States, 70115
        • Nola Research Works, LLC /ID# 161271
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisana Research Center, LLC /ID# 162239
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland /ID# 164766
    • Michigan
      • Troy, Michigan, United States, 48098-6363
        • Center for Digestive Health /ID# 154697
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 163084
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2000
        • University of Nebraska Medical Center /ID# 210056
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research /ID# 160167
      • Las Vegas, Nevada, United States, 89128-3157
        • Revival Research Institute, Inc /ID# 210986
    • New York
      • Brooklyn, New York, United States, 11235
        • NY Scientific /ID# 158272
      • Burnt Hills, New York, United States, 12027
        • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446
      • Fresh Meadows, New York, United States, 11366
        • Intercity Advanced Gastroentertology Center /ID# 215204
      • Great Neck, New York, United States, 11021-5343
        • Duplicate_Long Island Clinical Research /ID# 154843
      • New Hyde Park, New York, United States, 11040
        • Digestive Disease Care /ID# 211776
      • New Hyde Park, New York, United States, 11040
        • North Shore University Hospital /ID# 168734
      • New York, New York, United States, 10016-6402
        • NYU Langone Medical Center /ID# 160166
      • New York, New York, United States, 10022
        • Weill Cornell Medicine /ID# 165856
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 167545
      • New York, New York, United States, 10075
        • Lenox Hill Hospital /ID# 168466
      • North Massapequa, New York, United States, 11758
        • DiGiovanna Institute for Medical Education & Research /ID# 171130
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center /ID# 158364
      • Kinston, North Carolina, United States, 28501-1589
        • Vidant Multispecialty Clinic - Kinston /ID# 161109
      • Raleigh, North Carolina, United States, 27612
        • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891
    • North Dakota
      • Fargo, North Dakota, United States, 58104-5925
        • Plains Clinical Research Center, LLC /ID# 169712
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Tri-State Endoscopy /ID# 154939
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus /ID# 209225
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 164706
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 167877
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Resea /ID# 170447
      • Mentor, Ohio, United States, 44060-6211
        • Great Lakes Medical Research, LLC /ID# 201774
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical /ID# 211992
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists /ID# 170772
      • Tulsa, Oklahoma, United States, 74136-7823
        • Adult Gastroenterology Associates - Gen 1 Research /ID# 208857
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic /ID# 158255
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • PennState Milton S.Hershey Med /ID# 154894
      • Pittsburgh, Pennsylvania, United States, 15224-1334
        • Children's Hospital of Pittsburgh of UPMC /ID# 212543
      • Wyomissing, Pennsylvania, United States, 19610-2002
        • Digestive Disease Associates, LTD /ID# 208296
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina /ID# 212859
      • Greenville, South Carolina, United States, 29615-3593
        • Gastroenterology Associates, P.A. of Greenville /ID# 154919
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center - GI Research /ID# 163835
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 154757
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute /ID# 168735
      • Memphis, Tennessee, United States, 38119
        • Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 157110
    • Texas
      • Arlington, Texas, United States, 76012
        • TX Clinical Research Institute /ID# 159396
      • Baytown, Texas, United States, 77521-2415
        • Inquest Clinical Research /ID# 165696
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209781
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209945
      • Garland, Texas, United States, 75044-2208
        • DHAT Research Institute /ID# 158199
      • Houston, Texas, United States, 77017-2337
        • Vilo Research Group Inc /ID# 207654
      • Houston, Texas, United States, 77027-6812
        • CliniCore International, LLC /ID# 158191
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine - Baylor Medical Center /ID# 158194
      • Houston, Texas, United States, 77036
        • Precision Research Institute, LLC /ID# 201072
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 201218
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 161307
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 168772
      • Temple, Texas, United States, 76508-0001
        • Baylor Scott & White Medical Center- Temple /ID# 204129
      • Tyler, Texas, United States, 75701-4464
        • Tyler Research Institute, LLC /ID# 166795
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria /ID# 164284
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research /ID# 162992
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 154922
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City /ID# 161775
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center /ID# 159977
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology Associates /ID# 162101
      • Seattle, Washington, United States, 98101
        • Virginia Mason - Seattle Orthapedics /ID# 155577
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-1200
        • WVU Medicine /ID# 167942

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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
  • Demonstrated intolerance or inadequate response to biologic therapy for CD.
  • If female, participant must meet the contraception recommendations.

Exclusion Criteria:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participants with unstable doses of concomitant Crohn's disease therapy.
  • Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab).
  • Complications of Crohn's disease.
  • Having an ostomy or ileoanal pouch.
  • Known active Coronavirus Disease 2019 (COVID-19) infection.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Risankizumab Dose 1 (Induction Period 1)
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
EXPERIMENTAL: Risankizumab Dose 2 (Induction Period 1)
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
PLACEBO_COMPARATOR: Placebo (Induction Period 1)
Participants randomized to receive placebo for risankizumab in Induction Period 1.
Drug: placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.
EXPERIMENTAL: Risankizumab Dose 1 (Induction Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
EXPERIMENTAL: Risankizumab Dose 2 (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
EXPERIMENTAL: Risankizumab Dose 3 (Induction period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Time Frame: Week 12
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Week 12
US Specific: Percentage of Participants With Endoscopic Response
Time Frame: Week 12
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Week 12
Global Outside of US: Percentage of Participants With Clinical Remission
Time Frame: Week 12
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 12
Global Outside of US: Percentage of Participants With Endoscopic Response
Time Frame: Week 12
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
US Specific: Percentage of Participants With Clinical Remission
Time Frame: Week 12
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 12
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Time Frame: Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 4
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Time Frame: Week 12
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 12
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time Frame: Week 12
The FACIT-Fatigue scale is a 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. 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.
Week 12
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Time Frame: Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Week 4
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Time Frame: Week 12

Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Week 12
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Time Frame: Week 12
Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
Week 12
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
Time Frame: Week 12
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
Week 12
US Specific: Percentage of Participants With Endoscopic Remission
Time Frame: Week 12
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Week 12
US Specific: Percentage of Participants With Enhanced Clinical Response
Time Frame: Week 4
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 4
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Time Frame: Week 12
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Week 12
US Specific: Percentage of Participants With Enhanced Clinical Response
Time Frame: Week 12
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 12
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Time Frame: Week 12
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Week 12
US Specific: Percentage of Participants With CD-Related Hospitalization
Time Frame: Up to Week 12
Participants with at least one admission to the hospital due to Crohn's Disease.
Up to Week 12
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Time Frame: Week 12
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Week 12
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Time Frame: Week 12
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Week 12
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Time Frame: Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 4
Global Outside of US: Percentage of Participants With Clinical Remission
Time Frame: Week 4
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 4
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Time Frame: Week 12
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Week 12
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time Frame: Week 12
The FACIT-Fatigue scale is a 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. 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.
Week 12
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Time Frame: Week 12
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.
Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Time Frame: Week 12
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Week 12
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Time Frame: Week 12
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Time Frame: Week 4
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 4
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Time Frame: Week 12
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Week 12
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Time Frame: Week 12
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Week 12
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Time Frame: Week 12
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Week 12
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Time Frame: Week 12
Participants with at least one admission to the hospital due to Crohn's Disease.
Week 12
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Time Frame: Week 12
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Week 12
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
Time Frame: Week 12
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Week 12
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Time Frame: Week 12
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Week 12

Collaborators and Investigators

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

Sponsor

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

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)

December 18, 2017

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

May 19, 2021

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (ACTUAL)

April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-991
  • 2016-003190-17 (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 and 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, please refer to the link below.

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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

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

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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