Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT04524611
Other Study ID Numbers:
M20-259
First Submitted
August 19, 2020
First Posted
August 23, 2020
Last Update Posted
April 12, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Crohn's Disease (CD)
Drug: RisankizumabDrug: Ustekinumab

Study Design

Study TypeInterventional
Actual Enrollment527 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleA Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Study Start DateSeptember 29, 2020
Actual Primary Completion Date1yr 8mos from now
Actual Study Completion Date1yr 8mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Risankizumab Dose A Followed by Dose B
Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
Drug: Risankizumab
Intravenous (IV) Infusion
Ustekinumab
Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Drug: Ustekinumab
Intravenous (IV) infusion

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Achieving Clinical Remission at Week 24
    Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
  2. Percentage of Participants Achieving Endoscopic Remission
    Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
  3. Number of Participants Reporting Adverse Events
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Secondary Outcome Measures
  1. Percentage of Participants Achieving Clinical Remission at Week 48
    Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
  2. Percentage of Participants Achieving Endoscopic Response at Week 48
    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (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).
  3. Percentage of Participants Achieving Endoscopic Response at Week 24
    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (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).
  4. Percentage of Participants Achieving Steroid-Free Endoscopic Remission
    Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.
  5. Percentage of Participants Achieving Steroid-Free Clinical Remission
    Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Confirmed diagnosis of Crohn's disease (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 Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.
Exclusion Criteria
Current diagnosis of ulcerative colitis or indeterminate colitis.
Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
Currently know complications of CD (strictures, short bowel, etc).

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Advanced Gastroenterology, P.C /ID# 224396 | Chandler Arizona, United States, 85224-1636Southern California Res. Ctr. /ID# 223484 | Coronado California, United States, 92118-1408Hoag Memorial Hosp Presbyterian /ID# 224373 | Irvine California, United States, 92618United Medical Doctors /ID# 223486 | Los Alamitos California, United States, 90720-3309TLC Clinical Research Inc /ID# 223467 | Los Angeles California, United States, 90048Duplicate_UC Davis Medical Center /ID# 225700 | Sacramento California, United States, 95817Duplicate_University of California, San Francisco /ID# 223621 | San Francisco California, United States, 94158Duplicate_Western Connecticut Medical Group /ID# 223478 | Danbury Connecticut, United States, 06810Duplicate_Medical Research Center of CT /ID# 223540 | Hamden Connecticut, United States, 06518Yale Univ Digestive Diseases /ID# 224463 | New Haven Connecticut, United States, 06510Omega Research Maitland, LLC /ID# 223463 | DeBary Florida, United States, 32713-2260Nature Coast Clinical Research - Inverness /ID# 223600 | Inverness Florida, United States, 34452-4717University of Miami /ID# 223496 | Miami Florida, United States, 33136Gastroenterology Group Naples /ID# 223516 | Naples Florida, United States, 34102Advanced Research Institute, Inc /ID# 223470 | New Port Richey Florida, United States, 34653Endoscopic Research, Inc. /ID# 223505 | Orlando Florida, United States, 32803Duplicate_University of South Florida /ID# 224733 | Tampa Florida, United States, 33612Atlanta Gastro Assoc /ID# 223537 | Atlanta Georgia, United States, 30342Gastroenterology Associates of Central Georgia, LLC /ID# 223525 | Macon Georgia, United States, 31201Duplicate_The University of Chicago DCAM /ID# 223520 | Chicago Illinois, United States, 60637NorthShore University-Endeavor Health Evanston Hospital /ID# 223538 | Evanston Illinois, United States, 60201Southwest Gastroenterology /ID# 223509 | Oak Lawn Illinois, United States, 60453University of Louisville Hospital /ID# 223471 | Louisville Kentucky, United States, 40202GI Alliance /ID# 223508 | Baton Rouge Louisiana, United States, 70809Nola Research Works, LLC /ID# 223489 | New Orleans Louisiana, United States, 70115Louisiana Research Center, LLC /ID# 223503 | Shreveport Louisiana, United States, 71105-6800Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499 | Chevy Chase Maryland, United States, 20815Gastro Center of Maryland /ID# 223518 | Columbia Maryland, United States, 21045Massachusetts General Hospital /Id# 224335 | Boston Massachusetts, United States, 02114Beth Israel Deaconess Medical Center /ID# 228094 | Boston Massachusetts, United States, 02215-5400University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597 | Ann Arbor Michigan, United States, 48109AA Medical Research Center - Flint /ID# 224384 | Flint Michigan, United States, 48504Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465 | Wyoming Michigan, United States, 49519Mayo Clinic - Rochester /ID# 223506 | Rochester Minnesota, United States, 55905-0001Las Vegas Medical Research /ID# 223533 | Las Vegas Nevada, United States, 89113Univ New Mexico /ID# 223515 | Albuquerque New Mexico, United States, 87131NY Scientific /ID# 223479 | Brooklyn New York, United States, 11235Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048 | Burnt Hills New York, United States, 12027Intercity Advanced Gastroentertology Center /ID# 224313 | Fresh Meadows New York, United States, 11366North Shore University Hospital /ID# 224356 | New Hyde Park New York, United States, 11040The Mount Sinai Hospital /ID# 223687 | New York New York, United States, 10029Columbia Univ Medical Center /ID# 224215 | New York New York, United States, 10032-3725Lenox Hill Hospital /ID# 223534 | New York New York, United States, 10075Univ NC Chapel Hill /ID# 224405 | Chapel Hill North Carolina, United States, 27514-4220Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406 | Winston-Salem North Carolina, United States, 27157-0001Plains Clinical Research Center, LLC /ID# 223522 | Fargo North Dakota, United States, 58104-5925University of Cincinnati Medical Center /ID# 224614 | Cincinnati Ohio, United States, 45219-2364Cleveland Clinic Main Campus /ID# 223691 | Cleveland Ohio, United States, 44195DSI Research, LLC /ID# 234116 | Springboro Ohio, United States, 45066-1615Hightower Clinical /ID# 223566 | Oklahoma City Oklahoma, United States, 73102Digestive Disease Specialists /ID# 223528 | Oklahoma City Oklahoma, United States, 73112Penn State Milton S. Hershey Medical Center /ID# 224216 | Hershey Pennsylvania, United States, 17033-2360Guthrie Medical Group, PC /ID# 223910 | Sayre Pennsylvania, United States, 18840Digestive Disease Associates, LTD - Wyomissing /ID# 223462 | Wyomissing Pennsylvania, United States, 19610Medical University of South Carolina /ID# 223485 | Charleston South Carolina, United States, 29425Consultants in Gastroenterology - Columbia NE /ID# 224263 | Columbia South Carolina, United States, 29203-8902Gastroenterology Associates, P.A. of Greenville /ID# 223497 | Greenville South Carolina, United States, 29607Gastro One /ID# 223539 | Cordova Tennessee, United States, 38018Vanderbilt University Medical Center /ID# 224610 | Nashville Tennessee, United States, 37232-0011Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512 | Dallas Texas, United States, 75246Duplicate_DHAT Research Institute /ID# 223521 | Garland Texas, United States, 75044-2208Vilo Research Group Inc /ID# 223513 | Houston Texas, United States, 77017-2337Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488 | Houston Texas, United States, 77030-3411Clinical Associates in Research Therapeutics of America, LLC /ID# 223510 | San Antonio Texas, United States, 78212Southern Star Research Institute, LLC /ID# 223598 | San Antonio Texas, United States, 78229-5390Texas Digestive Disease Consultants - Southlake /ID# 224264 | Southlake Texas, United States, 76092Tyler Research Institute, LLC /ID# 223469 | Tyler Texas, United States, 75701University of Vermont Medical Center /ID# 224047 | Burlington Vermont, United States, 05401-1473Richmond VA Medical Center /ID# 223586 | Richmond Virginia, United States, 23249Virginia Mason Hospital & Medical Center /ID# 224253 | Seattle Washington, United States, 98101Harborview Medical Center /ID# 224464 | Seattle Washington, United States, 98104-2420West Virginia University Hospitals /ID# 223501 | Morgantown West Virginia, United States, 26506Hospital Britanico de Buenos Aires /ID# 223432 | Ciudad Autonoma de Buenos Aire Buenos Aires, Argentina, 1280Hospital Italiano de Buenos Aires /ID# 224550 | Ciudad Autonoma Buenos Aires Buenos Aires F.D., Argentina, 1199CINME Centro de Investigaciones Metabolicas /ID# 223447 | Ciudad Autonoma de Buenos Aire Buenos Aires F.D., Argentina, 1027Gedyt /ID# 224698 | Ciudad Autonoma de Buenos Aire Buenos Aires F.D., Argentina, 1115Duplicate_CEMIC /ID# 223670 | Ciudad Autonoma de Buenos Aire Buenos Aires F.D., Argentina, 1431Duplicate_Sanatorio 9 de Julio /ID# 226086 | San Miguel de Tucumán Tucumán Province, Argentina, 4000Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433 | Córdoba , Argentina, 5016Wollongong Hospital /ID# 224688 | Wollongong New South Wales, Australia, 2500Mater Misericordiae Limited /ID# 223642 | South Brisbane Queensland, Australia, 4101Griffith University /ID# 223641 | Southport Queensland, Australia, 4222Lyell McEwin Hospital /ID# 223643 | Elizabeth Vale South Australia, Australia, 5112Monash Health - Monash Medical Centre /ID# 224599 | Clayton Victoria, Australia, 3168Universitaetsklinikum St. Poelten /ID# 223437 | Sankt Pölten Lower Austria, Austria, 3100Medizinische Universitaet Wien /ID# 223438 | Vienna State of Vienna, Austria, 1090Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440 | Linz Upper Austria, Austria, 4010ZAS Palfijn /ID# 223907 | Merksem Antwerpen, Belgium, 2170Universite Libre de Bruxelles - Hopital Erasme /ID# 223902 | Anderlecht Brussels Capital, Belgium, 1070Cliniques Universitaires UCL Saint-Luc /ID# 223900 | Brussels Brussels Capital, Belgium, 1200Groupe Sante CHC - Clinique du MontLegia /ID# 223898 | Liège Liege, Belgium, 4000Duplicate_CHU UCL Namur - site Godinne /ID# 223905 | Godinne Namur, Belgium, 5530UZ Gent /ID# 223899 | Ghent Oost-Vlaanderen, Belgium, 9000Vitaz /Id# 224511 | Sint-Niklaas Oost-Vlaanderen, Belgium, 9100Universitair Ziekenhuis Leuven /ID# 223901 | Leuven Vlaams-Brabant, Belgium, 3000AZ-Delta. /ID# 223896 | Roeselare West-Vlaanderen, Belgium, 8800AZ Maria Middelares /ID# 223908 | Ghent , Belgium, 9000Duplicate_CHU de Liege /ID# 223904 | Liège , Belgium, 4000Faculdade de Medicina do ABC /ID# 223231 | Santo André La Spezia, Brazil, 09060-870Upeclin Fmb - Unesp /Id# 223234 | Botucatu São Paulo, Brazil, 18618-686Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 223233 | Ribeirão Preto São Paulo, Brazil, 14049-900Kaiser Clinica e Hospital Dia /ID# 223232 | São José do Rio Preto São Paulo, Brazil, 15015-110Hospital Tsaritsa Yoanna /ID# 223822 | Sofiya Sofia, Bulgaria, 1527Umbal Kaspela /ID# 223415 | Plovdiv , Bulgaria, 4001MHAT Knyaginya Klementina /ID# 223425 | Sofia , Bulgaria, 1233Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757 | Sofia , Bulgaria, 1407Duplicate_University of Calgary /ID# 223750 | Calgary Alberta, Canada, T2N 4Z6Allen Whey Khye Lim Professional Corporation /ID# 223755 | Edmonton Alberta, Canada, T5R 1W2Covenant Health /ID# 223753 | Edmonton Alberta, Canada, T6K 4B2Fraser Clinical Trials Inc /ID# 223742 | New Westminster British Columbia, Canada, V3L 3W4Percuro Clinical Research, Ltd /ID# 223747 | Victoria British Columbia, Canada, V8V 3M9QEII - Health Sciences Centre /ID# 223748 | Halifax Nova Scotia, Canada, B3H 2Y9London Health Sciences Centre - University Hospital /ID# 223741 | London Ontario, Canada, N6A 5A5Scott Shulman Medicine Professional Corporation /ID# 223754 | North Bay Ontario, Canada, P1B 2H3Mount Sinai Hospital /ID# 223752 | Toronto Ontario, Canada, M5G 1X5Axler, Toronto, ON. Canada /ID# 223740 | Toronto Ontario, Canada, M9V 0A9CISSS de la Monteregie /ID# 224399 | Greenfield Park Quebec, Canada, J4V 2H1CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744 | Lévis Quebec, Canada, G6V 3Z1Montreal General Hospital- McGill University Health Center /ID# 223743 | Montreal Quebec, Canada, H3G 1A4Duplicate_Duplicate_CHUS - Hopital Fleurimont /ID# 224819 | Sherbrooke Quebec, Canada, J1H 5N4Hospital Guillermo Grant Benavente de Concepción /ID# 223668 | Concepción Biobio, Chile, 4070038Hospital Las Higueras /ID# 223669 | Talcahuano Biobio, Chile, 1740000Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 224032 | Providencia Region Metropolitana Santiago, Chile, 7510086Anhui Provincial Hospital /ID# 224832 | Hefei Anhui, China, 230001Peking University Third Hospital /ID# 224479 | Beijing Beijing Municipality, China, 100191Chongqing General Hospital /ID# 232305 | Chongqing Chongqing Municipality, China, 400013Zhongshan Hospital Xiamen University /ID# 224663 | Xiamen Fujian, China, 361004Zhujiang Hospital of Southern Medical University /ID# 224524 | Guangzhou Guangdong, China, 510280The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 224416 | Guangzhou Guangdong, China, 510655The Second Affiliated Hospital of Zhengzhou University /ID# 224528 | Zhengzhou Henan, China, 450014Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545 | Wuhan Hubei, China, 430022Tongji Hospital Tongji Medical College of HUST /ID# 224428 | Wuhan Hubei, China, 430030Renmin Hospital of Wuhan University /ID# 224525 | Wuhan Hubei, China, 430060The Second Xiangya Hospital Of Central South University /ID# 224684 | Changsha Hunan, China, 410011Duplicate_The Third Xiangya Hospital of Central South University /ID# 224754 | Changsha Hunan, China, 410013Changzhou No.2 Peoples Hospital /ID# 238965 | Changzhou Jiangsu, China, 213000Nanjing Drum Tower Hospital /ID# 224746 | Nanjing Jiangsu, China, 210008Wuxi People's Hospital /ID# 224426 | Wuxi Jiangsu, China, 214023The First Affiliated Hospital of Nanchang University /ID# 224507 | Nanchang Jiangxi, China, 330006Shengjing Hospital of China Medical University /ID# 224478 | Shenyang Liaoning, China, 110022Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420 | Shanghai Shanghai Municipality, China, 200127West China Hospital, Sichuan University /ID# 224786 | Chengdu Sichuan, China, 610041The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 224662 | Hangzhou Zhejiang, China, 310009Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421 | Hangzhou Zhejiang, China, 310018Iscare Klinické Centrum /ID# 223279 | Prague Praha 9, Czechia, 190 00Nemocnice Ceske Budejovice a.s. /ID# 224219 | České Budějovice , Czechia, 370 01Hepato-Gastroenterologie HK, s.r.o. /ID# 223277 | Hradec Králové , Czechia, 500 12Nemocnice Pardubickeho kraje, a.s. /ID# 223256 | Pardubice , Czechia, 530 03Axon Clinical, s.r.o. /ID# 223260 | Prague , Czechia, 140 00Nemocnice Horovice - NH Hospital a.s /ID# 223276 | Prague , Czechia, 155 00Chu de Nice-Hopital Larchet Ii /Id# 223763 | Nice Alpes-Maritimes, France, 06202CHU Clermont-Ferrand /ID# 224529 | Clermont Auvergne-Rhône-Alpes, France, 63100APHM - Hopital Nord /ID# 223869 | Marseille Bouches-du-Rhone, France, 13015Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 223764 | Pessac Gironde, France, 33604CHU Montpellier - Hopital Saint Eloi /ID# 223860 | Montpellier Herault, France, 34295Duplicate_CHU Grenoble - Hopital Michallon /ID# 224091 | La Tronche Isere, France, 38700CHU Reims - Hôpital Robert Debre /ID# 224530 | Reims Marne, France, 51092Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 223767 | Vandœuvre-lès-Nancy Meurthe-et-Moselle, France, 54511CHRU Lille - Hopital Claude Huriez /ID# 223765 | Lille Nord, France, 59037Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 241098 | Nantes Pays de la Loire Region, France, 44000Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 223768 | St-Priest-en-Jarez Pays de la Loire Region, France, 42270Clinique Jules Verne /ID# 223870 | Nantes , France, 44300Polyclinique Grand Sud /ID# 224092 | Nîmes , France, 30932Hopital Universitaire Purpan Hopital Rangueil /ID# 224732 | Toulouse , France, 31059Hopital Beaujon /ID# 223863 | Clichy Île-de-France Region, France, 92110Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249859 | Neuilly-sur-Seine Île-de-France Region, France, 92200Universitaetsklinikum Freiburg /ID# 223406 | Freiburg im Breisgau Baden-Wurttemberg, Germany, 79106Universitatsklinikum Mannheim /ID# 223410 | Mannheim Baden-Wurttemberg, Germany, 68167Universitaetsklinikum Ulm /ID# 223400 | Ulm Baden-Wurttemberg, Germany, 89081Universitaetsklinikum Erlangen /ID# 223404 | Erlangen Bavaria, Germany, 91054Universitatsklinik Regensburg /ID# 223407 | Regensburg Bavaria, Germany, 93053Duplicate_Agaplesion Markus Krankenhaus /ID# 223673 | Frankfurt am Main Hesse, Germany, 60431Duplicate_Universitaetsklinikum Frankfurt /ID# 223396 | Frankfurt am Main Hesse, Germany, 60590Medizinische Hochschule Hannover /ID# 223402 | Hanover Lower Saxony, Germany, 30625Klinikum Lueneburg /ID# 223408 | Lüneburg Lower Saxony, Germany, 21339Praxiszentrum fuer Gastroenterologie /ID# 223409 | Grevenbroich North Rhine-Westphalia, Germany, 41515Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482 | Saarbrücken Saarland, Germany, 66111Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403 | Dresden Saxony, Germany, 01307Eugastro /ID# 223401 | Leipzig Saxony, Germany, 04103Otto-von-Guericke-Universitaet /ID# 223413 | Magdeburg Saxony-Anhalt, Germany, 39120Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395 | Kiel Schleswig-Holstein, Germany, 24105Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 229110 | Berlin , Germany, 10318MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411 | Berlin , Germany, 10825Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 223405 | Berlin , Germany, 13353DRK Kliniken Berlin Westend /ID# 223412 | Berlin , Germany, 14050Krankenhaus Waldfriede /ID# 223397 | Berlin-Zehlendorf , Germany, 14163Medizinisches Versorgungszentrum Portal 10 /ID# 224552 | Münster , Germany, 48155General Hospital of Athens Ippokratio /ID# 223344 | Athens Attica, Greece, 11527General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342 | Athens Attica, Greece, 11527General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340 | Nikaia Attica, Greece, 18454University General Hospital of Heraklion PA.G.N.I /ID# 223336 | Heraklion Crete, Greece, 71500General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338 | Athens , Greece, 10676University General Hospital of Ioannina /ID# 223339 | Ioannina , Greece, 45500General Hospital of Thessaloniki Hippokrateio /ID# 223887 | Thessaloniki , Greece, 54642Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774 | Szeged Csongrád megye, Hungary, 6725Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 223773 | Debrecen Hajdú-Bihar, Hungary, 4032Duplicate_Clinfan Szolgaltato Kft. /ID# 224751 | Szekszárd Tolna County, Hungary, 7100Clinexpert Kft /ID# 223775 | Budapest , Hungary, 1033Semmelweis Egyetem /ID# 223772 | Budapest , Hungary, 1085Yitzhak Shamir Medical Center /ID# 224686 | Ẕerifin Central District, Israel, 70300Shaare Zedek Medical Center /ID# 223549 | Jerusalem Jerusalem, Israel, 91031The Edith Wolfson Medical Center /ID# 227652 | Ashkelon Southern District, Israel, 5822000Soroka University Medical Center /ID# 223556 | Beersheba Southern District, Israel, 8410101The Chaim Sheba Medical Center /ID# 223557 | Ramat Gan Tel Aviv, Israel, 5265601Tel Aviv Sourasky Medical Center /ID# 223551 | Tel Aviv Tel Aviv, Israel, 6423906Rabin Medical Center. /ID# 223558 | Petah Tikva , Israel, 4941492Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 223330 | Bologna Emilia-Romagna, Italy, 40138Duplicate_Ospedale Policlinico San Martino /ID# 223329 | Genoa Genova, Italy, 16132Duplicate_Ospedale San Raffaele IRCCS /ID# 241167 | Milan Milano, Italy, 20132ASST Fatebenefratelli Sacco /ID# 223322 | Milan Milano, Italy, 20157ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335 | Rho Milano, Italy, 20017Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332 | Rome Roma, Italy, 00133Azienda Ospedaliera San Camillo Forlanini /ID# 223325 | Rome Roma, Italy, 00149Duplicate_Policlinico Agostino Gemelli /ID# 223323 | Rome Roma, Italy, 00168Duplicate_IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327 | Negrar Verona, Italy, 37024Azienda Ospedaliera G. Brotzu /ID# 241165 | Cagliari , Italy, 09121Duplicate_Ospedale San Giovanni Di Dio - Cagliari /ID# 223474 | Cagliari , Italy, 09124Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 223324 | Milan , Italy, 20122Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 223333 | Palermo , Italy, 90146Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179 | Mexicali Estado de Baja California, Mexico, 21200BRCR Global Mexico /ID# 223970 | Guadalajara Jalisco, Mexico, 44600Centro Medico Zambrano Hellion /ID# 224025 | San Pedro Garza García Nuevo León, Mexico, 66278Medical Care & Research SA de CV /ID# 223974 | Mérida Yucatán, Mexico, 97070Faicic S de Rl de Cv /Id# 226990 | Veracruz , Mexico, 91900Radboud Universitair Medisch Centrum /ID# 233750 | Nijmegen Gelderland, Netherlands, 6525 GAElisabeth Tweesteden Ziekenhuis /ID# 223229 | Tilburg North Brabant, Netherlands, 5022 GCAmsterdam UMC, locatie AMC /ID# 223228 | Amsterdam North Holland, Netherlands, 1105 AZUniversitair Medisch Centrum Utrecht /ID# 223696 | Utrecht , Netherlands, 3584 CXGastromed Sp. z o.o /ID# 223705 | Torun Kuyavian-Pomeranian Voivodeship, Poland, 87-100Malopolskie Centrum Kliniczne /ID# 223708 | Krakow Lesser Poland Voivodeship, Poland, 30-149Vivamed Sp. z o.o. /ID# 223706 | Warsaw Masovian Voivodeship, Poland, 03-580Duplicate_Institutul Clinic Fundeni /ID# 223914 | Bucharest Bucharest, Romania, 022328Duplicate_Univ Emergency Hosp Bucharest /ID# 223579 | Bucharest Bucharest, Romania, 050098Sana Monitoring /Id# 223682 | Bucharest , Romania, 011025Spitalul Clinic Colentina /ID# 223680 | Bucharest , Romania, 020121Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017 | Târgu Mureş , Romania, 540136Targu Mures Emergency Clinical County Hospital /ID# 223613 | Târgu Mureş , Romania, 540136Cabinet Particular Policlinic Algomed /ID# 223578 | Timișoara , Romania, 300002Immanuel Kant Baltic Federal University /ID# 224224 | Kaliningrad Kaliningrad Oblast, Russia, 236016National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222 | Moscow , Russia, 123423City Clinical Hospital No. 31 /ID# 224223 | Saint Petersburg , Russia, 197110Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302 | Banská Bystrica Banská Bystrica Region, Slovakia, 975 17KM Management, spol. s.r.o. /ID# 223304 | Nitra Nitra Region, Slovakia, 949 01Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580 | Nové Zámky Nitra Region, Slovakia, 940 34Duplicate_GASTRO I., s.r.o. /ID# 223303 | Prešov Presov, Slovakia, 080 01Lenasia Clinical Trial Centre /ID# 224306 | Johannesburg Gauteng, South Africa, 1820Dr MJ Prins /ID# 224304 | Cape Town Western Cape, South Africa, 7500Private Practice Dr MN Rajabally /ID# 223805 | Cape Town Western Cape, South Africa, 7800Spoke Research Inc /ID# 223803 | CAPE TOWN Milnerton Western Cape, South Africa, 7441Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456 | Junggu Daejeon Gwang Yeogsi, South Korea, 34943Duplicate_Dong-A University Hospital /ID# 223455 | 서구 Gyeongsangnam-do, South Korea, 49201Duplicate_Kangbuk Samsung Hospital /ID# 223452 | Seoul Seoul Teugbyeolsi, South Korea, 03181Samsung Medical Center /ID# 223453 | Seoul Seoul Teugbyeolsi, South Korea, 06351Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356 | Ferrol A Coruna, Spain, 15405Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 226554 | Santiago de Compostela A Coruna, Spain, 15706Hospital Universitario Germans Trias i Pujol /ID# 223436 | Badalona Barcelona, Spain, 08916Duplicate_Hospital Universitario de Bellvitge /ID# 225719 | L'Hospitalet de Llobregat Barcelona, Spain, 08907Hospital Universitario de Fuenlabrada /ID# 223371 | Fuenlabrada Madrid, Spain, 28942Hospital Universitario Puerta de Hierro - Majadahonda /ID# 223319 | Majadahonda Madrid, Spain, 28222Hospital Universitario Central de Asturias /ID# 223368 | Oviedo Principality of Asturias, Spain, 33011Hospital General Universitario de Alicante Doctor Balmis /ID# 223552 | Alicante , Spain, 03010Hospital Clinic de Barcelona /ID# 223355 | Barcelona , Spain, 08036Hospital General Universitario Gregorio Maranon /ID# 223317 | Madrid , Spain, 28007Hospital Clinico San Carlos /ID# 223367 | Madrid , Spain, 28040Hospital Universitario La Paz /ID# 223318 | Madrid , Spain, 28046Hospital Universitario Virgen Macarena /ID# 223315 | Seville , Spain, 41009Hospital Universitario Virgen del Rocio /ID# 223476 | Seville , Spain, 41013Hospital Clinico Universitario de Valencia /ID# 223321 | Valencia , Spain, 46010Hospital Universitario y Politecnico La Fe /ID# 223314 | Valencia , Spain, 46026Karolinska University Hospital Solna /ID# 223423 | Solna Stockholm County, Sweden, 171 64GHP Stockholm Gastro Center /ID# 223420 | Stockholm Stockholm County, Sweden, 114 28Duplicate_Falu Lasarett /ID# 227222 | Falun , Sweden, 791 31Danderyds sjukhus AB /ID# 223363 | Stockholm , Sweden, 182 88University Hospital Basel /ID# 223711 | Basel Town Canton of Basel-City, Switzerland, 4031Duplicate_Universitatsspital Zurich /ID# 223712 | Zurich Canton of Zurich, Switzerland, 8091Inselspital, Universitaetsspital Bern /ID# 223590 | Bern , Switzerland, 3010Gazi Universitesi Tip Fakultes /ID# 223386 | Yenimahalle Ankara, Turkey (Türkiye), 06560Ankara Univ Medical Faculty /ID# 223388 | Ankara , Turkey (Türkiye), 06590Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 223387 | Istanbul , Turkey (Türkiye), 34098Mersin University Medical /ID# 223385 | Mersin , Turkey (Türkiye), 33343Lviv Regional Clinical Hospital /ID# 223661 | Lviv Lviv Oblast, Ukraine, 79010Kyiv City Clinical Hospital No.18 /ID# 223700 | Kyiv , Ukraine, 01030Medical Center of LLC DIASERVIS /ID# 224249 | Zaporizhzhia , Ukraine, 69076Addenbrookes Hospital /ID# 223648 | Cambridge Cambridgeshire, United Kingdom, CB2 2QQRoyal Devon & Exeter Hospital /ID# 223644 | Exeter Devon, United Kingdom, EX2 5DWWestern General Hospital - NHS Lothian /ID# 223646 | Edinburgh Edinburgh, City of, United Kingdom, EH4 2XUDisc_Barts Health NHS Trust - The Royal London Hospital /ID# 223651 | London Greater London, United Kingdom, E1 2ESSt Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 223647 | London Greater London, United Kingdom, SE1 7EHKings College Hospital NHS Foundation Trust /ID# 223649 | London Greater London, United Kingdom, SE5 9RSSt George University Hospitals NHS Foundation Trust /ID# 223656 | London Greater London, United Kingdom, SW17 0QTUniversity Hospital Southampton NHS Foundation Trust /ID# 224351 | Southampton Hampshire, United Kingdom, SO16 6YDEast and North Hertfordshire NHS Trust /ID# 224607 | Stevenage Hertfordshire, United Kingdom, SG1 4ABQueen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 223653 | Glasgow Lanarkshire, United Kingdom, G51 4TFDuplicate_Nottingham University Hospitals NHS Trust /ID# 224179 | Nottingham Nottinghamshire, United Kingdom, NG5 1PBOxford University Hospitals NHS Foundation Trust /ID# 223645 | Oxford Oxfordshire, United Kingdom, OX3 9DUBelfast Health and Social Care Trust /ID# 224023 | Belfast , United Kingdom, BT9 7ABCalderdale and Huddersfield NHS Foundation Trust /ID# 223654 | Huddersfield , United Kingdom, HX3 0PWThe Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655 | Newcastle upon Tyne , United Kingdom, NE3 3HDNorthern Care Alliance NHS Group /ID# 223650 | Salford , United Kingdom, M6 8HDNHS Forth Valley /ID# 224657 | Stirling , United Kingdom, FK9 4SW
Investigators
Study Director: ABBVIE INC., AbbVie