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Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

  • Clinicaltrials.gov identifier

    NCT03440385

  • Recruitment Status

    Recruiting

  • First Posted

    February 22, 2018

  • Last update posted

    September 23, 2022

Study Description

Brief summary:

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

  • Condition or Disease:Crohn Disease
  • Intervention/Treatment: Drug: Ozanimod
    Other: Placebo
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 600 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: June 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Drug: Ozanimod
Specified dose on specified days
Placebo Comparator: Administration of Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150 [ Time Frame: Week 12 ]
  • Secondary Outcome Measures: 1. Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline [ Time Frame: Week 12 ]
  • 2. Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  • 3. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: Week 12 ]
  • 4. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  • 5. Proportion of participants with CDAI score < 150 with SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  • 6. Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points [ Time Frame: Week 12 ]
    Both no worse than baseline and an SES-CD ≤ 4 points and decrease ≥2 points
  • 7. Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    Both no worse than baseline and an SES-CD decrease from baseline of ≥ 50%
  • 8. Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score [ Time Frame: Week 12 ]
  • 9. Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
  • 10. Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
  • 11. Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: Crohn's disease for ≥ 3 months on endoscopy and on histological exam Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease) Exclusion Criteria: Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition Current stoma, ileal-anal pouch anastomosis, or fistula Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

Germany
Local Institution - 649
Keil

Germany
Gastroenterological Special Practice at Wittenbergplatz
Berlin

Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin

Germany
Local Institution - 653
Berlin

Germany
Charite - Universitätsmedizin Berlin
Berlin

Germany
Local Institution - 648
Berlin

Germany
Hospital Waldfriede e.V.
Berlin

Germany
Local Institution - 628
Berlin

Germany
Brandenburg City Hospital
Brandenburg an der Havel

Germany
Local Institution - 664
Brandenburg an der Havel

Germany
Local Institution - 732
Dachau

Germany
Medical Care Unit Dachau
Dachau

Germany
Klinikum Darmstadt
Darmstadt

Germany
Kliniken Essen-Mitte
Essen

Germany
Local Institution - 574
Frankfurt am Main

Germany
Johann Wolfgang Goethe University Hospital
Frankfurt am Main

Germany
Local Institution - 657
Frankfurt am Main

Germany
Local Institution - 658
Halle

Germany
Studiengesellschaft BSF
Halle

Germany
Local Institution - 656
Halle

Germany
University Hospital Halle (Saale)
Halle

Germany
Asklepios Klinik Hamburg
Hamburg

Germany
Local Institution - 652
Hamburg

Germany
Universitatsklinikum Schleswig-Holstein
Keil

Germany
Local Institution - 337
Leipzig

Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz

Germany
Local Institution - 667
Muenster

Germany
University Hospital Muenster
Muenster

Germany
Universitaetsklinikum Charite - Ruppiner Kliniken GmbH
Neuruppin

Germany
Local Institution - 661
Stuttgart

Germany
Robert-Bosch-Hospital
Stuttgart

Israel
Local Institution - 340
Tel-Aviv

Israel
Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center
Afula

Israel
Local Institution - 343
Afula

Israel
Asaf Harofeh Medical Center
Beer Jacob

Israel
Rambam Health Care Campus
Haifa

Israel
Clalit Health Services
Jerusalem

Israel
Local Institution - 349
Kfar-Saba

Israel
Meir Medical Center
Kfar-Saba

Israel
Local Institution - 341
Petah Tikva

Israel
Rabin Medical Center
Petah Tikva

Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv

Poland
Ars Medica
Wroclaw

Poland
Local Institution - 580
Czestochowa

Poland
Local Institution - 988
Elblag

Poland
St. John Paul 2nd Municipal Hospital in Elblag
Elblag

Poland
Local Institution - 579
Gdansk

Poland
Nicolaus Copernicus Hospital
Gdansk

Poland
Local Institution - 577
Gdynia

Poland
Local Institution - 906
Jelenia Gora

Poland
Private Medical Practice Miroslaw Fic
Jelenia Gora

Poland
BioVirtus Medical Centre
Jozefow

Poland
Local Institution - 757
Jozefow

Poland
Local Institution - 578
Katowice

Poland
Centrum Opieki Zdrowotnej Orkan Med
Ksawerow

Poland
Local Institution - 834
Ksawerow

Poland
Local Institution - 981
Lodz

Poland
LUX MED Centrum Medyczne - Lodz
Lodz

Poland
Polish Mother's Memorial Hospital - Research Institute
Lodz

Poland
Local Institution - 976
Nowy Targ

Poland
Non-Public Healthcare Facility Allmedica Clinical Trials
Nowy Targ

Poland
Office of Bartosz Korczowski, MD
Rzeszow

Poland
Endoskopia Sp. z o.o.
Sopot

Poland
Local Institution - 979
Sopot

Poland
Local Institution - 835
Szczecin

Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC
Szczecin

Poland
Local Institution - 586
Warsaw

Poland
WIP Warsaw IBD Point
Warsaw

Poland
Local Institution - 833
Warsaw

Poland
PRIMA LCC Specialist Clinics
Warsaw

Poland
Children's Memorial Health Institute
Warsaw

Poland
Local Institution - 807
Warsaw

Poland
Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1
Warszawa

Poland
Local Institution - 989
Warszawa

Poland
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
Wierzchoslawice

Poland
Local Institution - 893
Wierzchoslawice

Poland
Local Institution - 983
Wroclaw

Poland
LUX MED Centrum Medyczne - Wroclaw
Wroclaw

Poland
Local Institution - 984
Wroclaw

Poland
Wroclaw Medical University
Wroclaw

Poland
Jan Mikulicz Radecki University Hospital
Wroclaw

Poland
Clinical Research Center Early-Phase Research Facility
Wroclaw

Poland
Local Institution - 982
Wroclaw

Poland
LexMedica
Wroclaw

Poland
Local Institution - 831
Wroclaw

Poland
Local Institution - 987
Wroclaw

Poland
EMC Medical Institute S.A
Wroclaw

Poland
Local Institution - 832
Wroclaw

Slovakia
Gastromedic s.r.o.
Nove Zamky

Slovakia
Cliniq, s.r.o.
Bratislava

Slovakia
Local Institution - 900
Bratislava

Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava

Slovakia
Brezno gastroenterology center s.r.o.
Brezno

Slovakia
KM Management, spol. s r.o.
Nitra

Slovakia
Local Institution - 897
Nove Zamky

Slovakia
GASTRO I., s.r.o.
Presov

Slovakia
Local Institution - 898
Presov

Slovakia
Local Institution - 896
Rimavska Sobota

Slovakia
World of the Health Inc. General Hospital Rimavska Sobota
Rimavska Sobota

United States, Arizona
HonorHealth Research Institute
Scottsdale

United States, California
Kindred Medical Institute for Clinical Trials, LLC
Corona

United States, California
UCSD Medical Center
La Jolla

United States, California
OM Research
Lancaster

United States, California
OM Research
Lancaster

United States, California
Southern California Research Institute Medical Group, Inc.
Los Angeles

United States, California
Matrix Clinical Research Inc
Los Angeles

United States, California
Facey Medical Foundation (Parent)
Mission Hills

United States, California
Havana Research Institute LLC
Pasadena

United States, California
Local Institution - 093
Pasadena

United States, California
Sutter Medical Group
Roseville

United States, California
UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit
Sacramento

United States, California
UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit
Sacramento

United States, California
University of California at San Francisco
San Francisco

United States, California
Local Institution - 124
West Covina

United States, California
New Hope Research Development
West Covina

United States, Colorado
Peak Gastroenterology Associates
Colorado Springs

United States, Colorado
Peak Gastroenterology Associates
Colorado Springs

United States, Connecticut
Connecticut Clinical Research Foundation
Bristol

United States, Connecticut
Connecticut Clinical Research Foundation
Bristol

United States, Florida
Clinical Research of West Florida
Clearwater

United States, Florida
Local Institution - 166
Clearwater

United States, Florida
Local Institution - 084
Clermont

United States, Florida
South Lake Pain Institute
Clermont

United States, Florida
American Research Institute Inc
Cutler Bay

United States, Florida
Universal Axon Clinical Research
Doral

United States, Florida
Universal Axon Clinical Research
Doral

United States, Florida
Riverside Clinical Research
Edgewater

United States, Florida
SIH Research
Kissimmee

United States, Florida
SIH Research
Kissimmee

United States, Florida
Pioneer Clinical Research
Lighthouse Point

United States, Florida
Pioneer Clinical Research
Lighthouse Point

United States, Florida
Center For Advanced Gastroenterology
Maitland

United States, Florida
Galiz Research LLC
Miami Springs

United States, Florida
Galiz Research LLC
Miami Springs

United States, Florida
LMG Research
Miami

United States, Florida
Life Medical Center & Research, Inc.
Miami

United States, Florida
Life Medical Center & Research, Inc.
Miami

United States, Florida
Local Institution - 081
Miami

United States, Florida
Vista Health Research
Miami

United States, Florida
Bayside Clinical Research
New Port Richey

United States, Florida
Bayside Clinical Research
New Port Richey

United States, Florida
Omega Research Maitland, LLC
Orlando

United States, Florida
Omega Research Maitland, LLC
Orlando

United States, Florida
IMIC, Inc.
Palmetto Bay

United States, Florida
IMIC, Inc.
Palmetto Bay

United States, Florida
Theia Clinical Research, LLC
Pinellas Park

United States, Florida
Precision Clinical Research, LLC.
Sunrise

United States, Florida
University of South Florida
Tampa

United States, Florida
University Of South Florida
Tampa

United States, Florida
Apex Clinical Research
Tampa

United States, Florida
Guardian Angel Health Svcs Inc
Tampa

United States, Florida
Guardian Angel Health Svcs Inc
Tampa

United States, Georgia
Children's Healthcare of Atlanta
Atlanta

United States, Georgia
Emory Clinic
Atlanta

United States, Georgia
Emory Clinic
Atlanta

United States, Georgia
Atlanta Center For Gastroenterology, P.C.
Decatur

United States, Georgia
Atlanta Center For Gastroenterology, P.C.
Decatur

United States, Idaho
Grand Teton Research Group, PLLC
Idaho Falls

United States, Idaho
Grand Teton Research Group, PLLC
Idaho Falls

United States, Illinois
University of Chicago
Chicago

United States, Illinois
University Of Chicago
Chicago

United States, Indiana
MediSphere Medical Research Center, LLC
Evansville

United States, Indiana
Indiana University
Indianapolis

United States, Indiana
Indiana University
Indianapolis

United States, Kansas
Cotton ONeil Clinical Research Center Digestive Health
Topeka

United States, Kansas
Cotton ONeil Clinical Research Center Digestive Health
Topeka

United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge

United States, Louisiana
Gastroenterology Associates, Llc
Baton Rouge

United States, Louisiana
Clinical Trials of SW Louisiana LLC
Lake Charles

United States, Louisiana
Clinical Trials of SW Louisiana LLC
Lake Charles

United States, Louisiana
Tandem Clinical Research, LLC
Marrero

United States, Massachusetts
Harvard Medical School - Boston Children's Hospital
Boston

United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester

United States, Michigan
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo

United States, Michigan
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo

United States, Michigan
Henry Ford Medical Center - New Center One
Novi

United States, Michigan
Henry Ford Medical Center - New Center One
Novi

United States, Minnesota
University of Minnesota Medical Center
Minneapolis

United States, Minnesota
University Of Minnesota Medical Center
Minneapolis

United States, Minnesota
Mayo Clinic
Rochester

United States, Minnesota
Mayo Clinic
Rochester

United States, Missouri
Mid America Gastrointestinal Consultants
Kansas City

United States, Missouri
Mid America Gastrointestinal Consultants
Kansas City

United States, Nevada
Internal Medicine Specialists
Las Vegas

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon

United States, New York
Drug Trials America
Hartsdale

United States, New York
Drug Trials America
Hartsdale

United States, New York
Weill Cornell Medical College
New York

United States, New York
Concorde Medical Group
New York

United States, New York
TrialSpark
New York

United States, New York
DiGiovanna Institute for Medical Education And Research
North Massapequa

United States, New York
DiGiovanna Institute for Medical Education And Research
North Massapequa

United States, North Carolina
PMG Research of Charlotte LLC
Charlotte

United States, North Carolina
PMG Research of Winston-Salem LLC
Winston-Salem

United States, North Carolina
PMG Research of Winston-Salem LLC
Winston-Salem

United States, Ohio
University Hospitals of Cleveland
Cleveland

United States, Ohio
Advance Clinical Research - Dayton Internal Medicine
Dayton

United States, Ohio
Advance Clinical Research - Dayton Internal Medicine
Dayton

United States, Ohio
Local Institution - 049
Hilliard

United States, Ohio
Ohio State University Wexner Medical Center
Hilliard

United States, Ohio
Paramount Medical Research & Consulting, LLC
Middleburg Heights

United States, Oklahoma
Cancer Care Associates of OK-N PorterAvenue
Norman

United States, Oklahoma
Cancer Care Associates of OK-N PorterAvenue
Norman

United States, Oklahoma
Hightower Clinical
Oklahoma City

United States, Oklahoma
Allergy, Asthma and Immunology Center, PC
Tulsa

United States, Oklahoma
Allergy, Asthma and Immunology Center, PC
Tulsa

United States, Oklahoma
Central States Research, LLC
Tulsa

United States, Oklahoma
Essential Medical Research, LLC
Tulsa

United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia

United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia

United States, Texas
San Antonio Military Medical Center
Fort Sam Houston

United States, Texas
San Antonio Military Medical Center
Fort Sam Houston

United States, Texas
Centex Studies, Inc.
Houston

United States, Texas
Local Institution - 079
Houston

United States, Texas
The Coastal Medical Group
Houston

United States, Texas
Gulf Coast Research Group LLC
Houston

United States, Texas
Accurate Clinical Research Inc
Pasadena

United States, Texas
DHAT Research Institute
Richardson

United States, Texas
DHAT Research Institute
Richardson

United States, Texas
San Antonio Gastroenterology
San Antonio

United States, Texas
San Antonio Gastroenterology
San Antonio

United States, Texas
Baylor Scott and White Health
Temple

United States, Texas
Baylor Scott and White Health
Temple

United States, Virginia
Blue Ridge Medical Research
Lynchburg

United States, Virginia
Blue Ridge Medical Research
Lynchburg

United States, Virginia
The Gastroenterology Group
Reston

United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond

United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond

United States, Virginia
Carilion Clinic
Roanoke

United States, Wisconsin
Franciscan Skemp Healthcare
La Crosse

Australia, New South Wales
Liverpool Hospital
Liverpool

Australia, New South Wales
Local Institution - 309
Liverpool

Australia, New South Wales
John Hunter Hospital and Hunter Medical Research Institute
New Lambton Heights

Australia, New South Wales
Local Institution - 318
New Lambton Heights

Australia, Queensland
Coastal Digestive Health
Maroorchydore

Australia, Queensland
Local Institution - 313
Maroorchydore

Australia, Queensland
Local Institution - 321
North Mackay

Australia, Queensland
University of the Sunshine Coast
North Mackay

Australia, Queensland
Local Institution - 312
South Brisbane

Australia, Queensland
Mater Hospital Brisbane
South Brisbane

Australia, South Australia
Flinders Medical Centre
Bedford Park

Australia, Victoria
Monash Medical Centre
Clayton

Australia, Victoria
Local Institution - 305
Fitzroy

Australia, Victoria
St Vincent's Hospital Melbourne
Fitzroy

Australia, Victoria
Local Institution - 327
Melbourne

Australia, Western Australia
St John of God Subiaco Hospital
Subiaco

Austria
Local Institution - 726
Innsbruck

Austria
Medical University Innsbruck
Innsbruck

Austria
Local Institution - 727
St Polten

Austria
University Hospital St. Poelten
St Polten

Austria
Local Institution - 725
Vienna

Austria
Medical University Vienna
Vienna

Bulgaria
Local Institution - 753
Ruse

Bulgaria
MHAT Ruse AD
Ruse

Bulgaria
Excelsior Medical Center
Sofia

Bulgaria
Local Institution - 750
Sofia

Bulgaria
Local Institution - 755
Sofia

Bulgaria
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
Sofia

Bulgaria
Diagnostic and Consulting Center Alexandrovska
Sofia

Bulgaria
Local Institution - 756
Sofia

Bulgaria
Local Institution - 752
Sofia

Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
Sofia

Bulgaria
Local Institution - 554
Sofia

Canada, Alberta
Local Institution - 269
Edmonton

Canada, Alberta
West Edmonton Gastroenterology Consultants
Edmonton

Canada, British Columbia
Fraser Clinical Trials Inc.
New Westminister

Canada, British Columbia
Local Institution - 262
New Westminister

Canada, British Columbia
GI Research Institute
Vancouver

Canada, British Columbia
Local Institution - 267
Vancouver

Canada, Manitoba
Brandon Medical Arts Clinic
Brandon

Canada, Nova Scotia
IWK Health Center
Halifax

Canada, Ontario
Dr.Garisa Jagan Mohan Reddy MD
Sudbury

Canada, Ontario
Local Institution - 264
Toronto

Canada, Ontario
Mount Sinai Hospital
Toronto

Canada, Ontario
Kensington Screening Clinic
Toronto

Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal

Canada, Quebec
The Ottawa Hospital - General Campus
Ottawa

China, Shanghai
Local Institution - 369
Shanghai

China
Peking University First Hospital
Beijing

China
Peking University People's Hospital
Beijing

China
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University
Beijing

China
Local Institution - 482
Beijing

China
The Seventh Medical Center of PLA General Hospital
Beijing

China
First Hospital of Jilin University
Changchun

China
Local Institution - 422
Fuzhou

China
Guangzhou First People's Hospital
Guangzhou Shi

China
Local Institution - 472
Guangzhou Shi

China
Local Institution - 486
Guangzhou Shi

China
Local Institution - 470
Hangzhou, Zhejiang

China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang

China
Anhui Provincial Hospital
Hefei

China
Local Institution - 488
Nanchang

China
The First Affiliated Hospital of Nanchang University
Nanchang

China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing

China
Local Institution - 487
Nanjing

China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai

China
China Medical University Hospital
Taichung City

China
Local Institution - 458
Taichung City

China
Local Institution - 373
Tianjin

China
Local Institution - 483
Wuhan Shi

China
Local Institution - 475
Wuhan

China
Wuhan Union Hospital
Wuhan

China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan

China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou

China
The Second Affiliated Hospital Of Zhengzhou University
Zhengzhou

Colombia
Local Institution - 398
Barranquilla

Finland
Helsinki University Central Hospital (HUCH)
Helsinki

France
Centre Hospitalier de Blois
Blois Cedex

France
Beziers Hospital
Béziers

France
Local Institution - 634
Caen

France
University Hospital Center Caen
Caen

France
Assistance Publique - Hopitaux de Paris - Hopital Beaujon
Clichy

France
Louis Mourier Hospital
Colombes

France
CHU Nantes University Hospital - Hotel Dieu Hospital
Nantes

France
Local Institution - 632
Nantes

France
Local Institution - 647
Neuilly-sur-Seine

France
Local Institution - 630
Pierre-Benite

France
South Lyon Hospital Center
Pierre-Benite

France
Saint-Etienne University Hospital Center
Saint Priest en Jarez

Georgia
JSC Evex Medical Corporation - Batumi Referral Hospital
Batumi

Georgia
Local Institution - 786
Batumi

Georgia
JSC Evex Medical Corporation - Oncology Center
Kutaisi

Georgia
Local Institution - 779
Kutaisi

Georgia
Helsicore - Israeli Georgian Medical Research Clinic
Tbilisi

Georgia
Local Institution - 778
Tbilisi

Georgia
LLC Vivamedi
Tbilisi

Georgia
Local Institution - 782
Tbilisi

Georgia
Tbilisi State Medical University
Tbilisi

Georgia
Local Institution - 793
Tbilisi

Georgia
LTD Institute of Clinical Cardiology
Tbilisi

Georgia
JSC Infectious Disease, AIDS and Clinical Immunology Research Center
Tbilisi

Georgia
Local Institution - 783
Tbilisi

Georgia
Local Institution - 784
Tbilisi

Georgia
Local Institution - 785
Tbilisi

Georgia
LTD Academician N.Kipshidze Central University Clinic
Tbilisi

Georgia
LTD Aversi Clinic
Tbilisi

Georgia
LTD MediClub Georgia
Tbilisi

Georgia
Local Institution - 335
Tbilisi

Georgia
David Tatishvili Medical Center
Tbilisi

Georgia
Local Institution - 781
Tbilisi

Georgia
JSC Evex Medical Corporation - Telavi Referral Hospital
Telavi

Georgia
Local Institution - 780
Telavi

Greece
Laiko General Hospital of Athens
Athens

Greece
Local Institution - 588
Athens

Greece
Sotiria Chest Diseases Hospital of Athens
Athens

Greece
Tzanio General Hospital of Piraeus
Athens

Greece
PAGNI University Hospital
Heraklion

Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki

Greece
424th Army General Hospital
Thessaloniki

Greece
Local Institution - 788
Thessaloniki

Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Bekescsaba

Hungary
Local Institution - 798
Bekescsaba

Hungary
Local Institution - 803
Budapest

Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest

Hungary
Local Institution - 804
Budapest

Hungary
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar
Budapest

Hungary
Local Institution - 556
Budapest

Hungary
Local Institution - 801
Gyor

Hungary
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
Gyor

Hungary
CRU Hungary Kft
Miskolc

Hungary
Local Institution - 797
Miskolc

Hungary
Kanizsai Dorottya Hospital
Nagykanizsa

Hungary
Local Institution - 800
Nagykanizsa

Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar

Hungary
Local Institution - 799
Szekesfehervar

Hungary
Clinfan Ltd
Szekszárd

Hungary
Local Institution - 816
Szekszárd

Hungary
Csongrad County Dr. Bugyi Istvan Hospital
Szentes

Hungary
Local Institution - 805
Szentes

Hungary
Zala Megyei KorhazHaematologia
Zalaegerszeg

Korea, Republic of
Pusan National University Hospital
Busan

Korea, Republic of
Inje University Haeundae Paik Hospital
Busan

Korea, Republic of
Local Institution - 431
Busan

Korea, Republic of
Local Institution - 432
Daegu

Korea, Republic of
Yeungnam University Medical Center
Daegu

Korea, Republic of
Local Institution - 438
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Local Institution - 429
Suwon

Korea, Republic of
St. Vincent's Hospital
Suwon

Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas

Lithuania
Klaipeda University Hospital
Klaipeda

Lithuania
Local Institution - 603
Klaipeda

Lithuania
Vilnius University Hospital Santariskes Clinics
Vilnius

Lithuania
Local Institution - 606
Vilnius

Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius

Lithuania
Vilnius City Clinical Hospital
Vilnius

Netherlands
Local Institution - 952
Amsterdam

Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam

Netherlands
Academisch Medisch Centrum
Amsterdam

Netherlands
Local Institution - 955
Amsterdam

Netherlands
Local Institution - 956
Groningen

Netherlands
UMC Groningen
Groningen

Netherlands
Local Institution - 949
Nijmegen

Netherlands
Radboud University Medical Center
Nijmegen

Netherlands
Local Institution - 951
Sittard-Geleen

Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen

Netherlands
Local Institution - 954
Tilburg

Netherlands
St. Elisabeth Ziekenhuis
Tilburg

Portugal
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra
Coimbra

Portugal
Local Institution - 959
Coimbra

Portugal
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes
Guimaraes

Portugal
Hospital Beatriz Angelo
Loures

Portugal
Local Institution - 961
Loures

Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Viana do Castelo

Portugal
Local Institution - 957
Viana do Castelo

Russian Federation
Joint Venture Company Diagnostic Center, Bioterm Ltd.
Barnaul

Russian Federation
Local Institution - 966
Barnaul

Russian Federation
Local Institution - 871
Barnaul

Russian Federation
Territorial Clinical Hospital
Barnaul

Russian Federation
Regional Clinical Hospital #3
Chelyabinsk

Russian Federation
Chelyabinsk Regional Clinical Hospital
Chelyabinsk

Russian Federation
Local Institution - 991
Chelyabinsk

Russian Federation
Local Institution - 583
Ekaterinburg

Russian Federation
Local Institution - 872
Ekaterinburg

Russian Federation
Ural State Medical Academy - Medical Association Novaya Bolnitsa
Ekaterinburg

Russian Federation
Immanuel Kant Baltic Federal University
Kaliningrad

Russian Federation
Local Institution - 998
Kaliningrad

Russian Federation
Kaluga Regional Hospital
Kaluga

Russian Federation
Local Institution - 849
Kemerovo

Russian Federation
S.V. Beliaev Kemerovo Regional Clinical Hospital
Kemerovo

Russian Federation
Local Institution - 566
Moscow

Russian Federation
City Clinical Hospital n.a. V.M. Buyanov
Moscow

Russian Federation
Local Institution - 995
Moscow

Russian Federation
City Clinical Hospital 24
Moscow

Russian Federation
CJSC Nasledniki
Moscow

Russian Federation
Local Institution - 870
Moscow

Russian Federation
A.N. Ryzhikh State Research Center for Coloproctology
Moscow

Russian Federation
Local Institution - 990
Nizhny Novgorod

Russian Federation
Railway Station Clinical Hospital
Nizhny Novgorod

Russian Federation
Local Institution - 853
Novosibirsk

Russian Federation
Medical Center Sibnovomed LLC
Novosibirsk

Russian Federation
Local Institution - 876
Novosibirsk

Russian Federation
Scientific Research Institute of Physiology and Basic Medicine
Novosibirsk

Russian Federation
Euromed Multi-Specialty Center for Contemporary Medicine LLC
Omsk

Russian Federation
Local Institution - 996
Omsk

Russian Federation
Local Institution - 875
Orenburg

Russian Federation
Medical Diagnostic Center LLC
Orenburg

Russian Federation
N.N. Burdenko Penza Regional Clinical Hospital
Penza

Russian Federation
City Clinical Hospital No 31 - St. Petersburg
Saint Petersburg

Russian Federation
Local Institution - 874
Saint Petersburg

Russian Federation
Local Institution - 868
Saint-Petersburg

Russian Federation
S.M. Kirov Military Medical Academy
Saint-Petersburg

Russian Federation
Local Institution - 865
Samara

Russian Federation
Medical University REAVIZ
Samara

Russian Federation
Local Institution - 992
Saratov

Russian Federation
Regional Clinical Hospital
Saratov

Russian Federation
Sochi City Hospital No 5
Sochi

Russian Federation
Local Institution - 878
St Petersburg

Russian Federation
Oncology Center of Moskovskiy District
St Petersburg

Russian Federation
City Outpatient Care Unit No 38
St. Petersburg

Russian Federation
I.I. Mechnikov North-Western State Medical University
St. Petersburg

Russian Federation
Local Institution - 863
St. Petersburg

Russian Federation
Local Institution - 993
St. Petersburg

Russian Federation
Local Institution - 857
St. Petersburg

Russian Federation
State Unitary Enterprise Passengeravtotrans
St. Petersburg

Russian Federation
Local Institution - 879
St. Petersburg

Russian Federation
Medical Center Eko-Bezopasnost LLC
St. Petersburg

Russian Federation
Local Institution - 877
Tomsk

Russian Federation
Tomsk Regional Clinical Hospital
Tomsk

Russian Federation
G.G. Kuvatov Republican Clinical Hospital
Ufa

Russian Federation
Local Institution - 881
Ufa

Russian Federation
Local Institution - 880
Volgograd

Russian Federation
Medical Scientific Manufacturing Association Dvizheniye Clinic
Volgograd

Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
Belgrade

Serbia
Local Institution - 887
Belgrade

Serbia
Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje
Belgrade

Serbia
Clinical Hospital Center Zvezdara Clinic of Internal Diseases
Belgrade

Serbia
Local Institution - 596
Belgrade

Serbia
Local Institution - 886
Belgrade

Serbia
Local Institution - 890
Belgrade

Serbia
Military Medical Academy, Clinic of Gastroenterology and Hepatology
Belgrade

Serbia
Clinical Center Kragujevac
Kragujevac

Serbia
Local Institution - 891
Kragujevac

Serbia
Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology
Novi Sad

Serbia
General Hospital Pancevo
Pancevo

Serbia
Local Institution - 885
Pancevo

Serbia
General Hospital Djordje Jovanovic Zrenjanin
Zrenjanin

Serbia
Local Institution - 889
Zrenjanin

Slovenia
General Hospital Celje
Celje

Slovenia
Local Institution - 904
Celje

South Africa
Local Institution - 550
Cape town

South Africa
Ahmed Kathrada Private Hospital
Gauteng

South Africa
Local Institution - 543
Gauteng

South Africa
Local Institution - 545
Kempton Park

South Africa
Local Institution - 551
Molotlegi Street

South Africa
Emmed Research
Pretoria

South Africa
Local Institution - 542
Pretoria

Spain
Local Institution - 694
Barcelona

Spain
Teknon Medical Center
Barcelona

Spain
Local Institution - 702
Cordoba

Spain
University Hospital Reina Sofia
Cordoba

Spain
Local Institution - 699
Girona

Spain
University Hospital of Girona Dr. Josep Trueta
Girona

Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria

Spain
Hospital Clinico San Carlos
Madrid

Spain
Local Institution - 693
Majadahonda, Madrid

Spain
University Hospital Puerta de Hierro Majadajonda
Majadahonda, Madrid

Spain
Local Institution - 706
Santander

Spain
University Hospital Marques de Valdecilla (HUMV)
Santander

Spain
University Clinical Hospital of Valencia
Valencia

Spain
University Hospital Miguel Servet
Zaragoza

Sweden
Saint Goran Hospital
Stockholm

Sweden
Ersta Hospital
Stockholm

Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, San Ming Dist.

Taiwan
E-DA Hospital
Kaohsiung

Taiwan
Local Institution - 460
Kaohsiung

Taiwan
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital
Niao-Sung Hsiang Kaohsiung County

Taiwan
Local Institution - 459
Tainan, Taiana

Taiwan
National Cheng Kung University Hospital
Tainan, Taiana

Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan City

Taiwan
Local Institution - 462
Taoyuan City

Taiwan
Taipei Veterans General Hospital
Tapei, Beitou Dist.

Taiwan
Local Institution - 465
Tapei

Taiwan
National Taiwan University Hospital
Tapei

Turkey
Hacettepe Universitesi
Ankara

Turkey
Local Institution - 357
Ankara

Turkey
Firat University Medical Faculty
Elazig

Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul

Turkey
Local Institution - 361
Istanbul

Turkey
Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi
Istanbul

Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul

Turkey
Local Institution - 353
Kadiköy/Istanbul

Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi

Ukraine
Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2
Dnipropetrovsk

Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk

Ukraine
Local Institution - 929
Ivano-Frankivsk

Ukraine
Kharkiv City Clinical Hospital 2
Kharkiv

Ukraine
Local Institution - 965
Kharkiv

Ukraine
Khmelnytskyi Regional Hospital
Khmelnytskyi

Ukraine
Local Institution - 920
Khmelnytskyi

Ukraine
Local Institution - 933
Kropyvnytskyi

Ukraine
Medical and Diagnostic Center Acinus
Kropyvnytskyi

Ukraine
Medical Center Medical Clinic Blagomed LLC
Kyiv

Ukraine
Kyiv City Clinical Hospital #18
Kyiv

Ukraine
BIK-KYIV Ukrainian German Gastroenterology Center
Kyiv

Ukraine
Local Institution - 923
Kyiv

Ukraine
Local Institution - 564
Kyiv

Ukraine
Kyiv Regional Clinical Hospital
Kyiv

Ukraine
Local Institution - 977
Kyiv

Ukraine
Local Institution - 563
Kyiv

Ukraine
Local Institution - 590
Lutsk

Ukraine
Volyn Regional Clinical Hospital
Lutsk

Ukraine
Local Institution - 974
Lviv

Ukraine
Lviv Regional Clinical Hospital
Lviv

Ukraine
Local Institution - 902
Odesa

Ukraine
Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department
Odesa

Ukraine
Local Institution - 924
Vinnytsia

Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia

Ukraine
Health Clinic, LLC
Vinnytsya

Ukraine
Local Institution - 932
Vinnytsya

Ukraine
Multidisciplinary Clinic of the St. Nicholas, LLC
Zaporizhia

Ukraine
Local Institution - 925
Zaporizhzhya

Ukraine
Zaporizhzhya Regional
Zaporizhzhya

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03440385 History of Changes
  • Other Study ID Numbers: RPC01-3202, U1111-1203-7949, 2017-004293-33
  • First Posted: February 22, 2018 Key Record Dates
  • Last Update Posted: September 23, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Crohn's Disease
    Crohn Disease
    Ozanimod
    Moderately active
    Severely active
    RPC01
    RPC01-3202
    Oral
  • Additional relevant MeSH terms: Crohn Disease
    Inflammatory Bowel Diseases
    Gastroenteritis
    Gastrointestinal Diseases
    Digestive System Diseases
    Intestinal Diseases