A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

June 9, 2022 updated by: AbbVie

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

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
931

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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# 161988
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Duplicate_HOSPITAL CENTENARIO /ID# 170883
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Duplicate_Mater Hospital /ID# 167990
      • Southport, Queensland, Australia, 4222
        • Griffith University /ID# 212627
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital /ID# 211363
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 213511
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital /ID# 211361
  • Austria
    • Niederoesterreich
      • Sankt Poelten, Niederoesterreich, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 166425
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universitaet Graz /ID# 158137
    • Wien
      • Vienna, Wien, Austria, 1020
        • Krankenhaus der Barmherzigen Brueder Wien /ID# 212059
      • Vienna, Wien, Austria, 1090
        • Duplicate_Medical University of Vienna /ID# 158138
  • Belarus
      • Gomel, Belarus, 246029
        • Gomel Regional Clinical Hospital /ID# 159498
      • Grodno, Belarus, 230011
        • Grodno city clinical hospital #2 /ID# 159499
      • Витебск, Belarus, 210001
        • Vitebsk Regional Advanced Clin /ID# 159497
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis /ID# 157392
      • Liege, Belgium, 4000
        • CHU de Liege /ID# 157398
      • Liege, Belgium, 4000
        • Groupe Sante CHC - Clinique du MontLegia /ID# 157393
      • Roeselare, Belgium, 8800
        • AZ-Delta /ID# 157391
    • Bruxelles-Capitale
      • Brussels, Bruxelles-Capitale, Belgium, 1070
        • ULB Hospital Erasme /ID# 157397
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 157395
    • Namur
      • Godinne, Namur, Belgium, 5530
        • CHU UCL Namur - site Godinne /ID# 157401
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 157394
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 157396
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 165134
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 157717
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 164512
  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74535-170
        • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157672
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Hospital Nossa Senhora das Graças /ID# 157646
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 157653
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 157688
      • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157649
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 159672
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
        • Kaiser Clinica e Hospital Dia /ID# 157656
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT Dr Georgi Stranski EAD /ID# 203977
      • Plovdiv, Bulgaria, 4001
        • University Multiprofile Hospit /ID# 158644
      • Sofia, Bulgaria, 1202
        • Second Multiprofile Hospital f /ID# 158646
      • Sofia, Bulgaria, 1407
        • Duplicate_Tokuda Hospital Sofia /ID# 158645
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski /ID# 204714
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Joanna - ISUL /ID# 211240
      • Stara Zagora, Bulgaria, 6004
        • MHAT Trakia /ID# 201672
      • Varna, Bulgaria, 9010
        • University Multiprofile Hospit /ID# 167575
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary - Heritage Medical Research Clinic /ID# 157152
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 169761
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta - Zeidler Ledcor Centre /ID# 157098
      • Edmonton, Alberta, Canada, T6K 4B2
        • Covenant Health /ID# 161617
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc /ID# 159053
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 157095
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 161616
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII - Health Sciences Centre /ID# 157087
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Center /ID# 165900
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center /ID# 157160
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation /ID# 165903
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicor Research Inc /ID# 157149
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital /ID# 169762
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Asso /ID# 157157
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie /ID# 161615
      • Levis, Quebec, Canada, G6V 3Z1
        • CHAU- Hotel-Dieu de Levis /ID# 214375
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159054
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167066
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Center /ID# 157084
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 210759
      • Talcahuano, Chile, 1740000
        • Hospital Las Higueras /ID# 167090
    • Region Metropolitana De Santiago
      • Santiago, Region Metropolitana De Santiago, Chile, 8207257
        • Complejo Asistencial Dr. Sotero del Rio /ID# 169382
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 2540488
        • Centro de Investigaciones Clínicas Viña del Mar /ID# 203589
  • China
      • Changsha, China, 410011
        • The Second Hospital Central South University /ID# 211696
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University /ID# 210889
      • Pudong New District, China, 200136
        • Shanghai East Hospital /ID# 212683
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital /ID# 210927
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital /ID# 212948
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hosp Sun /ID# 210785
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University /ID# 212740
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210856
      • Wuhan, Hubei, China, 430022
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211038
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University /ID# 214873
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 211034
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210841
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210707
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210725
      • Hangzhou, Zhejiang, China, 310020
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210624
      • Jinhua, Zhejiang, China, 321000
        • Jinhua Municipal Central Hospital /ID# 215626
  • Colombia
      • Medellin, Colombia, 50010
        • Hospital Universitario San Vic /ID# 171487
    • Antioquia
      • Medellin, Antioquia, Colombia, 050024
        • Instituto de Coloproctologia /ID# 158741
      • Medellín, Antioquia, Colombia, 50034
        • Hospital Pablo Tobon Uribe /ID# 158735
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110231
        • Hospital Univ San Ignacio /ID# 158733
  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157565
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre milosrdnice /ID# 157721
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb /ID# 157566
    • Osjecko-baranjska Zupanija
      • Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
        • UHC Osijek /ID# 157564
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinicki bolnicki centar Split /ID# 157567
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 163134
      • Olomouc, Czechia, 779 00
        • CTCenter MaVe s.r.o. /ID# 163149
      • Pardubice, Czechia, 530 03
        • Nemocnice Pardubickeho kraje, a.s. /ID# 163182
      • Praha, Czechia, 118 33
        • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211305
      • Praha, Czechia, 140 00
        • Axon Clinical, s.r.o. /ID# 163176
      • Praha, Czechia, 140 59
        • Thomayerova nemocnice /ID# 162940
      • Praha, Czechia, 143 00
        • ResTrial s.r.o. /ID# 211075
      • Praha, Czechia, 155 00
        • NH Hospital a.s. /ID# 211076
    • Praha 4
      • Prague 4, Praha 4, Czechia, 140 00
        • Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165463
  • Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital /ID# 157077
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre /ID# 163507
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 10138
        • East Tallinn Central Hospital /ID# 157076
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212219
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212893
      • Berlin, Germany, 10787
        • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211972
      • Berlin, Germany, 10825
        • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159322
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend /ID# 166146
      • Berlin-Zehlendorf, Germany, 14163
        • Krankenhaus Waldfriede /ID# 212728
      • Braunschweig, Germany, 38126
        • Stadtisches Klinikum Braunschweig /ID# 163666
      • Dachau, Germany, 85221
        • Medizinisches Versorgunszentrum Dachau /ID# 211557
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus /ID# 159317
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg /ID# 159319
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 162021
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH /ID# 212076
      • Lueneburg, Germany, 21339
        • Klinikum Lueneburg /ID# 163664
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg /ID# 211847
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162018
      • Regensburg, Germany, 93042
        • Universitaetsklinikum Regensburg /ID# 163665
      • Wiesbaden, Germany, 65189
        • Duplicate_Gastro-Praxis Wiesbaden /ID# 159318
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg /ID# 162019
      • Heidelberg, Baden-Wuerttemberg, Germany, 69121
        • Praxis fuer Gastroenterologie /ID# 166145
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 162020
      • Tübingen, Baden-Wuerttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen /ID# 159324
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 164986
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 159315
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 212978
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 51103
        • Evangelisches Krankenhaus Kalk /ID# 212725
      • Grevenbroich, Nordrhein-Westfalen, Germany, 41515
        • Praxiszentrum fuer Gastroenterologie /ID# 211964
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln /ID# 164985
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 159316
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210529
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159321
    • Thueringen
      • Jena, Thueringen, Germany, 07747
        • Universitaetsklinikum Jena /ID# 159323
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157428
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 157425
      • Pireaus, Greece, 18454
        • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157429
      • Thessaloniki, Greece, 54639
        • Theageneio Anticancer Hospital /ID# 163921
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 171077
      • Piraeus, Attiki, Greece, 18536
        • Tzaneio general hospital of Piraeus /ID# 206445
    • Kriti
      • Heraklion, Kriti, Greece, 71307
        • University General Hospital of Heraklion PA.G.N.I /ID# 157427
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 163902
      • Tuen Mun, Hong Kong
        • Tuen Mun Hospital /ID# 163901
  • Ireland
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 157513
    • Dublin
      • Beaumont, Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 157515
      • Elm Park, Dublin, Ireland, D04 T6F4
        • St Vincent's University Hospital /ID# 157512
  • Israel
      • Haifa, Israel, 3109601
        • Duplicate_Rambam Medical Center /ID# 171072
      • Holon, Israel, 5822000
        • The Edith Wolfson Medical Center /ID# 217329
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 163540
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 171073
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 165913
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 157798
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5239424
        • Sheba Medical Center /ID# 157797
      • Ramat Gan, Tel-Aviv, Israel, 5239424
        • Sheba Medical Center /ID# 171074
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 157796
  • Italy
      • Bologna, Italy, 40138
        • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155635
      • Catania, Italy, 95126
        • A.O. Per L'Emergenza Cannizzaro /ID# 161306
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino /ID# 162430
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155633
      • Milano, Italy, 20157
        • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155631
      • Palermo, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155637
      • Pavia, Italy, 27100
        • Duplicate_Fondazione IRCCS Policlinico San Matteo /ID# 212029
    • Ancona
      • Torrette, Ancona, Italy, 60123
        • Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162427
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • University of Catanzaro /ID# 212012
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
        • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212019
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico /ID# 162429
      • Rome, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 155636
      • Rome, Lazio, Italy, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166911
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 155634
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 158021
      • Rome, Roma, Italy, 00168
        • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155632
    • Toscana
      • Florence, Toscana, Italy, 50139
        • Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168051
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161305
  • Japan
    • Aichi
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital /ID# 160159
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 160162
      • Nagoya-shi, Aichi, Japan, 457-0818
        • Daido Clinic /ID# 211477
      • Nagoyashi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 160150
      • Toyoake-shi, Aichi, Japan, 470-1192
        • Fujita Health University Hospital /ID# 163214
    • Chiba
      • Abiko-shi, Chiba, Japan, 270-1168
        • Tokatsu Tsujinaka Hospital /ID# 163362
      • Chiba-shi, Chiba, Japan, 260-8677
        • Chiba University Hospital /ID# 217532
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Tsujinaka Hospital Kashiwanoha /ID# 213847
      • Kashiwa-shi, Chiba, Japan, 277-8567
        • The Jikei University Kashiwa Hospital /ID# 200007
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center /ID# 160161
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 217792
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 160138
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center /ID# 163578
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 160139
    • Hokkaido
      • Midorigaokahiga-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 162844
      • Sapporo-shi, Hokkaido, Japan, 004-0041
        • Sapporo Tokushukai Hospital /ID# 213493
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160158
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 163028
    • Hyogo
      • Nishinomiya-shi, Hyogo, Japan, 663-8014
        • Nishinomiya Munic Central Hospital /ID# 210104
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine College Hospital /Id# 160164
    • Ibaraki
      • Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
        • National Hospital Organization Mito Medical Center /ID# 160154
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital /ID# 201766
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Gokeikai Ofuna Chuo Hospital /ID# 171070
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital /ID# 171071
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 163906
      • Yokohama-shi, Kanagawa, Japan, 240-8555
        • Yokohama Municipal Citizen's Hospital /ID# 204126
    • Mie
      • Tsu-shi, Mie, Japan, 514-8507
        • Mie University Hospital /ID# 203639
      • Yokkaichi-shi, Mie, Japan, 510-0016
        • Yokkaichi Hazu Medical Center /ID# 163741
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 162843
      • Sendai-shi, Miyagi, Japan, 981-8563
        • Duplicate_Tohoku Rosai Hospital /ID# 163189
    • Osaka
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka City University Hospital /ID# 160146
    • Saitama
      • Kawagoe-shi, Saitama, Japan, 350-8550
        • Saitama Medical Center /ID# 160155
      • Saitama-shi, Saitama, Japan, 336-0963
        • Tokitokai Tokito clinic /ID# 160145
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 164022
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital /ID# 205689
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • NHO Shizuoka Medical Center /ID# 163029
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University, Medical Hospital /ID# 160157
      • Hachioji-shi, Tokyo, Japan, 192-0032
        • Duplicate_Tokai University Hachioji Hospital /ID# 160160
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 163190
      • Minato-ku, Tokyo, Japan, 108-8642
        • Duplicate_Kitasato University Kitasato Institute Hospital /ID# 160144
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University Hospital /ID# 160149
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 205973
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital /ID# 200183
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 200154
    • Yamanashi
      • Kofu-shi, Yamanashi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital /ID# 160156
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 158675
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 158677
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center /ID# 158680
      • Daejeon, Korea, Republic of, 34943
        • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213552
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 158678
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 158674
    • Gyeonggido
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Hanyang University Guri Hospital /ID# 158673
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
        • Duplicate_CHA bundang medical center CHA University /ID# 158672
      • Suwon, Gyeonggido, Korea, Republic of, 16247
        • Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 158681
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 158676
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Severance Hospital /ID# 158671
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital /ID# 159614
      • Riga, Latvia, LV-1079
        • Digestive Disease Center Gastro /ID# 163105
      • Riga, Latvia, LV-1079
        • Riga East Clinical University Hospital /ID# 159613
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Duplicate_Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 162582
      • Vilnius, Lithuania, LT-08661
        • Duplicate_Vilnius University Hospital /ID# 162507
  • Malaysia
      • Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia /ID# 160656
    • Sabah
      • Division Pantai Barat Utara, Sabah, Malaysia, 88200
        • Queen Elizabeth Hospital /ID# 160654
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 56000
        • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 163654
  • Mexico
      • Del. Benito Juárez, Mexico, 03810
        • Health Pharma Professional Research S.A de C.V /ID# 161734
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 167648
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • JM Research SC /ID# 161733
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Unidad de Atencion Medica e Investigacion en Salud /ID# 163624
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 157950
      • Tilburg, Netherlands, 5022 GC
        • Elisabeth Tweesteden Ziekenhuis /ID# 163631
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Christchurch Hospital /ID# 163074
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Dunedin Hospital /ID# 167989
    • Wellington
      • Newtown Wellington, Wellington, New Zealand, 6021
        • Wellington Regional Hospital /ID# 167987
  • Norway
      • Gjettum, Norway, 1346
        • Vestre viken - Baerum Sykehus /ID# 157886
      • Levanger, Norway, 7601
        • Sykehuset Levanger Helse NT /ID# 157885
      • Ålesund, Norway, 6017
        • Helse More og Romsdal HF, Alesund sjukehus /ID# 212811
    • Akershus
      • Nordbyhagen, Akershus, Norway, 1474
        • Akershus universitetssykehus /ID# 169378
  • Poland
      • Poznan, Poland, 60-529
        • Duplicate_SOLUMED Sp. z o.o., Sp.k. /ID# 160793
      • Warsaw, Poland, 03-580
        • Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 205160
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212602
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 52-210
        • Planetmed Sp. z o.o. /ID# 202798
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • Gastromed /Id# 212099
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212297
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-049
        • 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209985
      • Lublin, Lubelskie, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209981
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 160794
      • Warszawa, Mazowieckie, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 160797
      • Warszawa, Mazowieckie, Poland, 04-730
        • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213579
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-326
        • Centrum Medyczne Medyk /ID# 212889
    • Pomorskie
      • Chojnice, Pomorskie, Poland, 89-600
        • Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212081
    • Slaskie
      • Tychy, Slaskie, Poland, 43-100
        • H-T. Centrum Medyczne - Endoterapia /ID# 212459
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-561
        • Wojewodzki Szpital Specjalistyczny /ID# 212402
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta, EPE /ID# 160747
      • Faro, Portugal, 8000-386
        • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160715
      • Lisboa, Portugal, 1169-050
        • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160675
      • Lisboa, Portugal, 1349-019
        • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167749
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160694
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Ângelo /ID# 207757
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160695
      • Viseu, Portugal, 3504-509
        • Centro Hosp de Tondela-Viseu /ID# 160697
    • Braga
      • Guimaraes, Braga, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160739
    • Faro
      • Portimão, Faro, Portugal, 8500-338
        • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167750
    • Porto
      • Santa Maria Da Feira, Porto, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga /ID# 160674
  • Romania
      • Cluj, Romania, 400132
        • Tvm Med Serv Srl /Id# 166294
      • Timisoara, Romania, 300168
        • Duplicate_Centrul Medical Tuculanu SRL /ID# 166295
      • Timișoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed /ID# 163047
    • Bucuresti
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 163046
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 163264
  • Russian Federation
      • Moscow, Russian Federation, 123423
        • State Scientific Ctr Coloproct /ID# 204809
      • Novosibirsk, Russian Federation, 630007
        • Novosibirski Gastrocenter /ID# 217554
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital No. 31 /ID# 208866
      • Ulyanovsk, Russian Federation, 432063
        • Duplicate_Ulyanovsk State clinical hospi /ID# 156946
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650099
        • Kuzbass Regional Clinical Hospital /ID# 161310
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614990
        • Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207440
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194100
        • Duplicate_St. Petersburg State Pediatric Medical University /ID# 211977
    • Stavropol Skiy Kray
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
        • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 156949
    • Tverskaya Oblast
      • Tver, Tverskaya Oblast, Russian Federation, 170036
        • Tver Regional Clinical Hospital /ID# 205925
    • Tyumenskaya Oblast
      • Tyumen, Tyumenskaya Oblast, Russian Federation, 625023
        • Regional Clinical Hospital #1 /ID# 163453
    • Udmurtskaya Respublika
      • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
        • Alliance Biomedical Ural Group /ID# 156950
  • Serbia
      • Belgrade, Serbia, 11000
        • University Children's Hospital 'Tirsova' /ID# 211481
      • Belgrade, Serbia, 11040
        • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212797
      • Leskovac, Serbia, 16000
        • General Hospital Leskovac /ID# 209574
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 156978
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 156979
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 156973
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 156976
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 156975
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clinical Center Vojvodina /ID# 156972
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 160658
      • Singapore, Singapore, 169608
        • Singapore General Hospital /ID# 160657
      • Singapore, Singapore, 228510
        • KL Ling Gastroenterology and Liver Clinic /ID# 205737
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156465
      • Martin, Slovakia, 036 01
        • Univerzitna nemocnica Martin /ID# 163200
      • Nitra, Slovakia, 949 01
        • KM Management, spol. s.r.o. /ID# 206763
      • Presov, Slovakia, 080 01
        • GASTRO I., s.r.o. /ID# 156466
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1619
        • Clinresco Centers /ID# 163864
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Site /ID# 158115
    • Western Cape
      • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
        • Spoke Research Inc /ID# 158117
      • Cape Town, Western Cape, South Africa, 7708
        • Kingsbury Hospital /ID# 163116
      • Cape Town, Western Cape, South Africa, 7800
        • Private Practice Dr MN Rajabally /ID# 163115
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 157526
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 161435
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 159228
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca /ID# 157532
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 160819
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 157530
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa /ID# 212523
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet /ID# 157531
    • A Coruna
      • Ferrol, A Coruna, Spain, 15405
        • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157527
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159230
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157575
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital Universitario Basurto /ID# 205189
  • Sweden
      • Molndal, Sweden, 431 80
        • Duplicate_SU Molndal. /ID# 157880
      • Solna, Sweden, 171 64
        • Duplicate_Karolinska Univ Sjukhuset /ID# 209966
    • Skane Lan
      • Malmo, Skane Lan, Sweden, 214 28
        • Skane University hospital /ID# 211235
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sweden, 114 28
        • Duplicate_GHP Stockholm Gastro Center /ID# 210479
      • Stockholm, Stockholms Lan, Sweden, 116 91
        • Ersta diakoni /ID# 157878
      • Stockholm, Stockholms Lan, Sweden, 182 88
        • Danderyd Hospital /ID# 202136
    • Vastra Gotalands Lan
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
        • Sahlgrenska University Hospital /ID# 157879
  • Switzerland
      • Basel, Switzerland, 4031
        • Duplicate_Universitaetsspital Basel /ID# 164555
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 163531
    • Zuerich
      • Zürich, Zuerich, Switzerland, 8091
        • Universitätsspital Zürich /ID# 163532
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165649
      • Kherson, Ukraine, 73000
        • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212050
      • Kyiv, Ukraine, 02091
        • International Institute of Clinical Research LLC /ID# 211997
      • Kyiv, Ukraine, 02232
        • Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165651
      • Kyiv, Ukraine, 03037
        • Medical Center of LLC Medbud-Clinic /ID# 216929
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hosp No.2 /ID# 217330
      • Lutsk, Ukraine, 43005
        • Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206788
      • Lviv, Ukraine, 79000
        • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165650
      • Uzhhorod, Ukraine, 88000
        • Duplicate_Transcarpathian Regional Clin. /ID# 168419
      • Vinnytsia, Ukraine, 21018
        • MNPE Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrohov /ID# 216265
      • Київ, Ukraine, 01030
        • Kyiv Municipal Clinical Hospital #18 /ID# 162521
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21029
        • Scientific Research Institute of Invalid Rehabilitation /ID# 211516
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust /ID# 158031
      • Edinburgh, United Kingdom, EH3 9HE
        • NHS Lothian /ID# 207447
      • Huddersfield, United Kingdom, HX3 0PW
        • Calderdale and Huddersfield NHS Foundation Trust /ID# 209569
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust /ID# 158757
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust /ID# 157523
      • London, United Kingdom, SE5 9RS
        • Duplicate_King's College Hospital NHS Foundation Trusts /ID# 158756
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163709
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 158033
      • Salford, United Kingdom, M6 8HD
        • Duplicate_Northern Care Alliance NHS Group /ID# 207764
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon and Exeter NHS Trust Hospital /ID# 157517
    • London, City Of
      • London, London, City Of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 163710
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust /ID# 157519
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207937
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System /ID# 162267
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Shea /ID# 161783
      • Tempe, Arizona, United States, 85284-2604
        • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211883
      • Tucson, Arizona, United States, 85724
        • University of Arizona /ID# 158469
    • Arkansas
      • Little Rock, Arkansas, United States, 72209-7040
        • Atria Clinical Research /ID# 164740
    • California
      • Huntington Beach, California, United States, 92648-5994
        • Newport Huntington Medica /ID# 213033
      • Los Alamitos, California, United States, 90720-3309
        • United Medical Doctors /ID# 207040
      • Los Angeles, California, United States, 90048
        • TLC Clinical Research Inc /ID# 212503
      • Los Angeles, California, United States, 90067-2001
        • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162656
      • Murrieta, California, United States, 92563
        • United Medical Doctors - Murrieta /ID# 158424
      • Riverside, California, United States, 92501
        • Southern CA Research Ctr., Inc /ID# 167875
      • San Francisco, California, United States, 94158
        • University of California, San Francisco /ID# 157143
      • West Hollywood, California, United States, 90048
        • Cedars-Sinai Medical Center-West Hollywood /ID# 163842
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates, PC /ID# 165834
      • Lone Tree, Colorado, United States, 80124-6798
        • Rocky Mountain Pediatric Gastroenterology /ID# 207169
    • Connecticut
      • Danbury, Connecticut, United States, 06810-6000
        • Western Connecticut Medical Group /ID# 165849
    • Florida
      • Brandon, Florida, United States, 33510
        • Seffner Premier Health Care, PA /ID# 162265
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 204859
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc /ID# 207450
      • Clermont, Florida, United States, 34711
        • South Lake Pain Institute, Inc /ID# 162825
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research /ID# 165432
      • Inverness, Florida, United States, 34452-4717
        • Nature Coast Clinical Research - Inverness /ID# 159414
      • Kissimmee, Florida, United States, 34741-4161
        • SIH Research Mumtaz, Inc /ID# 163082
      • Lighthouse Point, Florida, United States, 33064
        • Alliance Medical Research /ID# 163840
      • Maitland, Florida, United States, 32751-6108
        • Cfagi Llc /Id# 201571
      • Miami, Florida, United States, 33176-1032
        • Vista Health Research, LLC /ID# 212664
      • Miami, Florida, United States, 33176
        • ITB Research /ID# 161334
      • Miami, Florida, United States, 33186-4643
        • Coral Research Clinic /ID# 158549
      • Miami, Florida, United States, 33193
        • South Florida Research Ph I-IV, Inc. /ID# 161836
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Naples /ID# 165206
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 161959
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 205901
      • Orlando, Florida, United States, 32810-2907
        • Omega Research Maitland, LLC /ID# 171081
      • Palmetto Bay, Florida, United States, 33157
        • IMIC Inc. Medical Research /ID# 154943
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc. /ID# 201014
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 154857
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Division of GI/Hepatology /ID# 158283
      • Chicago, Illinois, United States, 60637-1443
        • The University of Chicago Medical Center /ID# 157141
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem /ID# 158287
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology /ID# 165002
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Res Ctr /ID# 154738
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center /ID# 157137
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /ID# 210521
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates LLC - Jefferson Hwy /ID# 161956
      • Houma, Louisiana, United States, 70360
        • Houma Digestive Health Special /ID# 158286
      • New Orleans, Louisiana, United States, 70115
        • Delricht Research /ID# 206542
      • New Orleans, Louisiana, United States, 70115
        • Nola Research Works, LLC /ID# 161330
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisana Research Center, LLC /ID# 162236
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154839
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland /ID# 165004
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems /ID# 157144
      • Troy, Michigan, United States, 48098-6363
        • Center for Digestive Health /ID# 154690
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161328
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 163085
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC /ID# 162388
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • St. Louis University /ID# 161902
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2000
        • University of Nebraska Medical Center /ID# 210057
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research /ID# 160172
      • Las Vegas, Nevada, United States, 89128-3157
        • Revival Research Institute, Inc /ID# 210984
    • New York
      • Brooklyn, New York, United States, 11235
        • NY Scientific /ID# 158418
      • Burnt Hills, New York, United States, 12027
        • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 212036
      • Fresh Meadows, New York, United States, 11366
        • Intercity Advanced Gastroentertology Center /ID# 213399
      • Great Neck, New York, United States, 11021-5343
        • Duplicate_Long Island Clinical Research /ID# 154836
      • New Hyde Park, New York, United States, 11040
        • Digestive Disease Care /ID# 209619
      • New Hyde Park, New York, United States, 11040
        • North Shore University Hospital /ID# 168736
      • New York, New York, United States, 10016-6402
        • NYU Langone Medical Center /ID# 160171
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 161911
      • New York, New York, United States, 10075
        • Lenox Hill Hospital /ID# 168465
      • North Massapequa, New York, United States, 11758
        • DiGiovanna Institute for Medical Education & Research /ID# 171118
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514-4220
        • Univ NC Chapel Hill /ID# 154840
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center /ID# 158481
      • Hickory, North Carolina, United States, 28601
        • Clinical Trials America /ID# 158484
      • Kinston, North Carolina, United States, 28501-1589
        • Vidant Multispecialty Clinic - Kinston /ID# 161111
      • Raleigh, North Carolina, United States, 27612
        • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154880
    • North Dakota
      • Fargo, North Dakota, United States, 58104-5925
        • Plains Clinical Research Center, LLC /ID# 169715
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Tri-State Endoscopy /ID# 154933
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus /ID# 208171
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 164709
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 167901
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Resea /ID# 170453
      • Mentor, Ohio, United States, 44060-6211
        • Great Lakes Medical Research, LLC /ID# 201732
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical /ID# 211938
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists /ID# 170774
      • Tulsa, Oklahoma, United States, 74136-7823
        • Adult Gastroenterology Associates - Gen 1 Research /ID# 206125
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic /ID# 158288
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • PennState Milton S.Hershey Med /ID# 154883
      • Pittsburgh, Pennsylvania, United States, 15224-1334
        • Children's Hospital of Pittsburgh of UPMC /ID# 210920
      • Wyomissing, Pennsylvania, United States, 19610-2002
        • Digestive Disease Associates, LTD /ID# 208847
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina /ID# 212579
      • Greenville, South Carolina, United States, 29615-3593
        • Gastroenterology Associates, P.A. of Greenville /ID# 154911
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center - GI Research /ID# 163841
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 154742
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute /ID# 168737
      • Memphis, Tennessee, United States, 38119-4823
        • Duplicate_Clinical Neuroscience Solutions /ID# 164181
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 157138
    • Texas
      • Arlington, Texas, United States, 76012
        • TX Clinical Research Institute /ID# 159410
      • Baytown, Texas, United States, 77521-2415
        • Inquest Clinical Research /ID# 165695
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209596
      • Cedar Park, Texas, United States, 78613-5028
        • Texas Digestive Disease Consultants /ID# 209785
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 201848
      • Garland, Texas, United States, 75044-2208
        • DHAT Research Institute /ID# 158217
      • Houston, Texas, United States, 77017-2337
        • Vilo Research Group Inc /ID# 206130
      • Houston, Texas, United States, 77027-6812
        • CliniCore International, LLC /ID# 158209
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine - Baylor Medical Center /ID# 158212
      • Houston, Texas, United States, 77036
        • Precision Research Institute, LLC /ID# 200503
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 200720
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 161336
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 168770
      • Tyler, Texas, United States, 75701-4464
        • Tyler Research Institute, LLC /ID# 166796
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria /ID# 164296
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research /ID# 162998
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 154914
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City /ID# 161781
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire DV AMC /ID# 159990
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology Associates /ID# 162120
      • Seattle, Washington, United States, 98101
        • Virginia Mason - Seattle Orthapedics /ID# 155545
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-1200
        • WVU Medicine /ID# 167940

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

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

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.
  • Diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
  • Demonstrated intolerance or inadequate response to conventional or 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 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Risankizumab Dose 1 (Period 1)
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Drug: risankizumab IV
Risankizumab administered by intravenous infusion
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
Experimental: Risankizumab Dose 2 (Period 1)
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Drug: risankizumab IV
Risankizumab administered by intravenous infusion
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
Placebo Comparator: Placebo (Period 1)
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Drug: placebo for risankizumab
Placebo for risankizumab administered by intravenous infusion
Experimental: Risankizumab Dose 1 (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 by intravenous infusion
Other Names:
  • SKYRIZI
  • ABBV-066 BI 655066
Experimental: Risankizumab Dose 2 (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 (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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 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 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 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
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at
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: 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 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 Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M16-006
  • 2016-003123-32 (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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