Clinical trial NCT04524611: 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)
Official title: A 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Crohn's Disease (CD)
Keywords: Crohn's Disease (CD)
Risankizumab
Ustekinumab
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving Endoscopic Remission
timeFrame: Week 48
measure: Number of Participants Reporting Adverse Events
timeFrame: Up to 220 Weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants Achieving Endoscopic Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants Achieving Endoscopic Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving Steroid-Free Endoscopic Remission
timeFrame: Week 48
measure: Percentage of Participants Achieving Steroid-Free Clinical Remission
timeFrame: Week 48
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Advanced Gastroenterology, P.C /ID# 224396
state: Arizona
city: Coronado
country: United States
facility: Southern California Res. Ctr. /ID# 223484
state: California
city: Irvine
country: United States
facility: Hoag Memorial Hosp Presbyterian /ID# 224373
state: California
city: Los Alamitos
country: United States
facility: United Medical Doctors /ID# 223486
state: California
city: Los Angeles
country: United States
facility: TLC Clinical Research Inc /ID# 223467
state: California
city: Sacramento
country: United States
facility: Duplicate_UC Davis Medical Center /ID# 225700
state: California
city: San Francisco
country: United States
facility: Duplicate_University of California, San Francisco /ID# 223621
state: California
city: Danbury
country: United States
facility: Duplicate_Western Connecticut Medical Group /ID# 223478
state: Connecticut
city: Hamden
country: United States
facility: Duplicate_Medical Research Center of CT /ID# 223540
state: Connecticut
city: New Haven
country: United States
facility: Yale Univ Digestive Diseases /ID# 224463
state: Connecticut
city: DeBary
country: United States
facility: Omega Research Maitland, LLC /ID# 223463
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research - Inverness /ID# 223600
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 223496
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Naples /ID# 223516
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc /ID# 223470
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc. /ID# 223505
state: Florida
city: Tampa
country: United States
facility: Duplicate_University of South Florida /ID# 224733
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastro Assoc /ID# 223537
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC /ID# 223525
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago DCAM /ID# 223520
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem /ID# 223538
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology /ID# 223509
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 223471
state: Kentucky
city: Baton Rouge
country: United States
facility: GI Alliance /ID# 223508
state: Louisiana
city: New Orleans
country: United States
facility: Nola Research Works, LLC /ID# 223489
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC /ID# 223503
state: Louisiana
city: Chevy Chase
country: United States
facility: Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland /ID# 223518
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital /Id# 224335
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 228094
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
state: Michigan
city: Flint
country: United States
facility: AA Medical Research Center - Flint /ID# 224384
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 223506
state: Minnesota
city: Las Vegas
country: United States
facility: Las Vegas Medical Research /ID# 223533
state: Nevada
city: Albuquerque
country: United States
facility: Univ New Mexico /ID# 223515
state: New Mexico
city: Brooklyn
country: United States
facility: NY Scientific /ID# 223479
state: New York
city: Burnt Hills
country: United States
facility: Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
state: New York
city: Fresh Meadows
country: United States
facility: Intercity Advanced Gastroentertology Center /ID# 224313
state: New York
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 224356
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital /ID# 223687
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 224215
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital /ID# 223534
state: New York
city: Chapel Hill
country: United States
facility: Univ NC Chapel Hill /ID# 224405
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center /ID# 224406
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC /ID# 223522
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center /ID# 224614
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 223691
state: Ohio
city: Springboro
country: United States
facility: DSI Research, LLC /ID# 234116
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical /ID# 223566
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists /ID# 223528
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center /ID# 224216
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group, PC /ID# 223910
state: Pennsylvania
city: Wyomissing
country: United States
facility: Digestive Disease Associates, LTD /ID# 223462
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 223485
state: South Carolina
city: Columbia
country: United States
facility: Consultants in Gastroenterology - Columbia NE /ID# 224263
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, P.A. of Greenville /ID# 223497
state: South Carolina
city: Cordova
country: United States
facility: Gastro One /ID# 223539
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 224610
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512
state: Texas
city: Garland
country: United States
facility: Duplicate_DHAT Research Institute /ID# 223521
state: Texas
city: Houston
country: United States
facility: Vilo Research Group Inc /ID# 223513
state: Texas
city: Houston
country: United States
facility: Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 223510
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC /ID# 223598
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake /ID# 224264
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC /ID# 223469
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 224047
state: Vermont
city: Richmond
country: United States
facility: Richmond VA Medical Center /ID# 223586
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Hospital & Medical Center /ID# 224253
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center /ID# 224464
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals /ID# 223501
state: West Virginia
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires /ID# 224550
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas /ID# 223447
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Gedyt /ID# 224698
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Britanico de Buenos Aires /ID# 223432
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Cemic /Id# 223670
state: Ciudad Autonoma De Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Duplicate_Sanatorio 9 de Julio /ID# 226086
state: Tucuman
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433
city: Wollongong
country: Australia
facility: Wollongong Hospital /ID# 224688
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited /ID# 223642
state: Queensland
city: Southport
country: Australia
facility: Griffith University /ID# 223641
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital /ID# 223643
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 224599
state: Victoria
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 223437
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
state: Oberoesterreich
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 223438
state: Wien
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 223902
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 223900
state: Bruxelles-Capitale
city: Godinne
country: Belgium
facility: Duplicate_CHU UCL Namur - site Godinne /ID# 223905
state: Namur
city: Gent
country: Belgium
facility: UZ Gent /ID# 223899
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 224511
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 223901
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 223896
state: West-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares /ID# 223908
city: Liege
country: Belgium
facility: CHU de Liege /ID# 223904
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 223898
city: Merksem
country: Belgium
facility: ZNA - Jan Palfijn /ID# 223907
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC /ID# 223231
state: La Spezia
city: Botucatu
country: Brazil
facility: Upeclin Fmb - Unesp /Id# 223234
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 223233
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Kaiser Clinica e Hospital Dia /ID# 223232
state: Sao Paulo
city: Sofiya
country: Bulgaria
facility: Hospital Tsaritsa Yoanna /ID# 223822
state: Sofia
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela EOOD /ID# 223415
city: Sofia
country: Bulgaria
facility: 2nd Mhat /ID# 223425
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757
city: Calgary
country: Canada
facility: University of Calgary /ID# 223750
state: Alberta
city: Edmonton
country: Canada
facility: Allen Whey Khye Lim Professional Corporation /ID# 223755
state: Alberta
city: Edmonton
country: Canada
facility: Covenant Health /ID# 223753
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc /ID# 223742
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 223747
state: British Columbia
city: Halifax
country: Canada
facility: QEII - Health Sciences Centre /ID# 223748
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Center- University Hospital /ID# 223741
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medicine Professional Corporation /ID# 223754
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital /ID# 223752
state: Ontario
city: Toronto
country: Canada
facility: Axler, Toronto, ON. Canada /ID# 223740
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 224399
state: Quebec
city: Levis
country: Canada
facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 224819
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital- McGill University Health Center /ID# 223743
city: Santiago
country: Chile
facility: Sociedad de Servicios Medicos Walsen Galmez /ID# 224032
state: Region Metropolitana De Santiago
city: Concepción
country: Chile
facility: Hospital Guillermo Grant Benavente de Concepción /ID# 223668
city: Talcahuano
country: Chile
facility: Hospital Las Higueras /ID# 223669
city: Hefei
country: China
facility: Anhui Provincial Hospital /ID# 224832
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 224479
state: Beijing
city: Chongqing
country: China
facility: Chongqing General Hospital /ID# 232305
state: Chongqing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University /ID# 224663
state: Fujian
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University /ID# 224524
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hosp Sun /ID# 224416
state: Guangdong
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University /ID# 224528
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 224428
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University /ID# 224525
state: Hubei
city: Changsha
country: China
facility: Duplicate_The Third Xiangya Hospital of Central South University /ID# 224754
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital /ID# 238965
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 224746
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital /ID# 224426
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 224507
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University /ID# 224478
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 224786
state: Sichuan
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 224662
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421
state: Zhejiang
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University /ID# 224684
city: Prague
country: Czechia
facility: Iscare Klinické Centrum /ID# 223279
state: Praha 9
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s. /ID# 224219
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 223277
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje, a.s. /ID# 223256
city: Praha
country: Czechia
facility: Axon Clinical, s.r.o. /ID# 223260
city: Praha
country: Czechia
facility: Nemocnice Horovice - NH Hospital a.s /ID# 223276
city: Nice
country: France
facility: Chu de Nice-Hopital Larchet Ii /Id# 223763
state: Alpes-Maritimes
city: Clermont
country: France
facility: CHU Clermont-Ferrand /ID# 224529
state: Auvergne-Rhone-Alpes
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 223869
state: Bouches-du-Rhone
city: Pessac
country: France
facility: Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 223764
state: Gironde
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 223860
state: Herault
city: Clichy
country: France
facility: Hopital Beaujon /ID# 223863
state: Ile-de-France
city: Neuilly Sur Seine
country: France
facility: Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249859
state: Ile-de-France
city: La Tronche
country: France
facility: Duplicate_CHU Grenoble - Hopital Michallon /ID# 224091
state: Isere
city: Reims CEDEX
country: France
facility: CHU Reims - Hôpital Robert Debre /ID# 224530
state: Marne
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 223767
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 223765
state: Nord
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 241098
state: Pays-de-la-Loire
city: Nantes
country: France
facility: Clinique Jules Verne /ID# 223870
city: Nimes Cedex
country: France
facility: Polyclinique Grand Sud /ID# 224092
city: St-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 223768
city: Toulouse
country: France
facility: Hopital Universitaire Purpan Hopital Rangueil /ID# 224732
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg /ID# 223406
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 223410
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 223400
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 223404
state: Bayern
city: Ratisbon
country: Germany
facility: Universitatsklinik Regensburg /ID# 223407
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Duplicate_Agaplesion Markus Krankenhaus /ID# 223673
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 223396
state: Hessen
city: Grevenbroich
country: Germany
facility: Praxiszentrum fuer Gastroenterologie /ID# 223409
state: Nordrhein-Westfalen
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482
state: Saarland
city: Leipzig
country: Germany
facility: Eugastro /ID# 223401
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395
state: Schleswig-Holstein
city: Berlin-Zehlendorf
country: Germany
facility: Krankenhaus Waldfriede /ID# 223397
city: Berlin
country: Germany
facility: Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405
city: Berlin
country: Germany
facility: Praxis Dr. Michael Mross /ID# 229110
city: Berlin
country: Germany
facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend /ID# 223412
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 223402
city: Lueneburg
country: Germany
facility: Klinikum Lueneburg /ID# 223408
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitaet /ID# 223413
city: Muenster
country: Germany
facility: Medizinisches Versorgungszentrum Portal 10 /ID# 224552
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 223344
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 223336
state: Kriti
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 223339
city: Nikaia
country: Greece
facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 223887
city: Szeged
country: Hungary
facility: Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
state: Csongrad
city: Debrecen
country: Hungary
facility: Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 223773
state: Hajdu-Bihar
city: Szekszard
country: Hungary
facility: Duplicate_Clinfan Szolgaltato Kft. /ID# 224751
state: Tolna
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 223775
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 223772
city: Ashkelon
country: Israel
facility: The Edith Wolfson Medical Center /ID# 227652
state: HaDarom
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 223556
state: HaDarom
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center /ID# 224686
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 223557
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 223551
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 223549
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 223558
city: Genoa
country: Italy
facility: Ospedale Policlinico San Martino /ID# 223329
state: Genova
city: Milan
country: Italy
facility: Ospedale San Raffaele IRCCS /ID# 241167
state: Milano
city: Rho
country: Italy
facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335
state: Milano
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini /ID# 223325
state: Roma
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 223323
state: Roma
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
state: Verona
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu /ID# 241165
city: Cagliari
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333
city: 중구
country: Korea, Republic of
facility: Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
state: Daejeon Gwang Yeogsi
city: 서구
country: Korea, Republic of
facility: Duplicate_Dong-A University Hospital /ID# 223455
state: Gyeongsangnamdo
city: Seoul
country: Korea, Republic of
facility: Duplicate_Kangbuk Samsung Hospital /ID# 223452
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 223453
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
state: Baja California
city: Guadalajara
country: Mexico
facility: BRCR Global Mexico /ID# 223970
state: Jalisco
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion /ID# 224025
state: Nuevo Leon
city: Mérida
country: Mexico
facility: Medical Care & Research SA de CV /ID# 223974
state: Yucatan
city: Veracruz
country: Mexico
facility: Faicic S de Rl de Cv /Id# 226990
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 233750
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC /ID# 223228
state: Noord-Holland
city: Tilburg
country: Netherlands
facility: Elisabeth Tweesteden Ziekenhuis /ID# 223229
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 223696
city: Torun
country: Poland
facility: Gastromed Sp. z o.o /ID# 223705
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne /ID# 223708
state: Malopolskie
city: Warszawa
country: Poland
facility: NZOZ Vivamed Jadwiga Miecz /ID# 223706
state: Mazowieckie
city: Bucharest
country: Romania
facility: Duplicate_Institutul Clinic Fundeni /ID# 223914
state: Bucuresti
city: Bucharest
country: Romania
facility: Sana Monitoring /Id# 223682
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina /ID# 223680
city: Bucuresti
country: Romania
facility: Univ Emergency Hosp Bucharest /ID# 223579
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017
city: Targu Mures
country: Romania
facility: Targu Mures Emergency Clinical County Hospital /ID# 223613
city: Timișoara
country: Romania
facility: Cabinet Particular Policlinic Algomed /ID# 223578
city: Kaliningrad
country: Russian Federation
facility: Immanuel Kant Baltic Federal University /ID# 224224
state: Kaliningradskaya Oblast
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital No. 31 /ID# 224223
city: Nitra
country: Slovakia
facility: KM Management, spol. s.r.o. /ID# 223304
state: Nitriansky Kraj
city: Presov
country: Slovakia
facility: Duplicate_GASTRO I., s.r.o. /ID# 223303
state: Presovsky Kraj
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580
city: Johannesburg
country: South Africa
facility: Lenasia Clinical Trial Centre /ID# 224306
state: Gauteng
city: CAPE TOWN Milnerton
country: South Africa
facility: Spoke Research Inc /ID# 223803
state: Western Cape
city: Cape Town
country: South Africa
facility: Dr MJ Prins /ID# 224304
state: Western Cape
city: Cape Town
country: South Africa
facility: Private Practice Dr MN Rajabally /ID# 223805
state: Western Cape
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356
state: A Coruna
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 226554
state: A Coruna
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias /ID# 223368
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 223436
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Duplicate_Hospital Universitario de Bellvitge /ID# 225719
state: Barcelona
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada /ID# 223371
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 223319
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 223552
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 223355
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 223317
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 223367
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 223318
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 223315
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 223476
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 223321
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 223314
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 223423
state: Stockholms Lan
city: Stockholm
country: Sweden
facility: GHP Stockholm Gastro Center /ID# 223420
state: Stockholms Lan
city: Falun
country: Sweden
facility: Duplicate_Falu Lasarett /ID# 227222
city: Stockholm
country: Sweden
facility: Danderyds sjukhus AB /ID# 223363
city: Basel Town
country: Switzerland
facility: Universitätsspital Basel /ID# 223711
state: Basel-Stadt
city: Zurich
country: Switzerland
facility: Duplicate_Universitatsspital Zurich /ID# 223712
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 223590
city: Yenimahalle
country: Turkey
facility: Gazi Universitesi Tip Fakultes /ID# 223386
state: Ankara
city: Ankara
country: Turkey
facility: Ankara Univ Medical Faculty /ID# 223388
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387
city: Mersin
country: Turkey
facility: Mersin University Medical /ID# 223385
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital No.18 /ID# 223700
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital /ID# 223661
city: Zaporizhzhia
country: Ukraine
facility: Medical Center of LLC DIASERVIS /ID# 224249
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital /ID# 223648
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital /ID# 223644
state: Devon
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 224351
state: Hampshire
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire NHS Trust /ID# 224607
state: Hertfordshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 223651
state: London, City Of
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 223647
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Duplicate_Nottingham University Hospitals NHS Trust /ID# 224179
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 223645
state: Oxfordshire
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 223653
state: Scotland
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust /ID# 224023
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 223646
city: Huddersfield
country: United Kingdom
facility: Calderdale and Huddersfield NHS Foundation Trust /ID# 223654
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 223649
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 223650
city: Stirling
country: United Kingdom
facility: NHS Forth Valley /ID# 224657
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust /ID# 223656
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: