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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

    March 3, 2021

Study Description

Brief summary:

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects 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 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: April 2023
  • Estimated Study Completion Date: July 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation
Drug: Ozanimod
Ozanimod
Placebo Comparator: Administration of Placebo
Subjects will receive placebo capsule orally starting with a 7-day dose escalation
Other: Placebo
Placebo

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of subjects with a CDAI score < 150 [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Secondary Outcome Measures: 1. Proportion of subjects 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 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.
  • 2. Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.
  • 3. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 4. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 5. Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
  • 6. Proportion of subjects 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: Up to approximately week 12 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
  • 7. Proportion of subjects 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: Up to approximately week 12 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
  • 8. Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) [ Time Frame: Week 12 ]
    Global Histologic Disease Activity score is a measure of histologic inflammation.
  • 9. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • 10. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
  • 11. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The CDEIS assesses the degree of endoscopic inflammation.
  • 12. Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points [ Time Frame: Up to approximately week 12 ]
    The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
  • 13. Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline [ Time Frame: Up to approximately week 12 ]
    The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
  • 14. Assessment of circulating lymphocyte concentration [ Time Frame: Up to approximately week 12 ]
    T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.
  • 15. Assessment of gene expression [ Time Frame: Up to approximately week 12 ]
    Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.
  • 16. Assessment of protein biomarker concentration [ Time Frame: Up to approximately week 12 ]
    Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.
  • 17. Assessment of pharmacogenetics [ Time Frame: Up to approximately week 12 ]
    Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.
  • 18. Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD [ Time Frame: Up to approximately week 12 ]
    SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients

Eligibility Criteria

  • Ages Eligible for Study: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Aged 12-75 years 2. Crohn's disease for ≥ 3 months on endoscopy and on histological exam 3. Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy 4. Patient has met each of the following clinical and endoscopic criteria: 1. Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450. 2. Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points. 3. SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease) Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment or at the time point specified in the following criteria: 1. Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. 2. Current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgement, surgical or medical intervention within 12 weeks of entry into the study, or need for ileostomy or colostomy.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

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
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
Sutter Medical Group
Roseville

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
New Hope Research Development
West Covina

United States, Colorado
Peak Gastroenterology Associates
Colorado Springs

United States, Connecticut
Connecticut Clinical Research Foundation
Bristol

United States, Florida
Clinical Research of West Florida
Clearwater

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
Riverside Clinical Research
Edgewater

United States, Florida
SIH Research
Kissimmee

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
LMG Research
Miami

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

United States, Florida
Vista Health Research
Miami

United States, Florida
Bayside Clinical Research
New Port Richey

United States, Florida
Omega Research Maitland, LLC
Orlando

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
Apex Clinical Research
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
Atlanta Center For Gastroenterology, P.C.
Decatur

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

United States, Illinois
University of Chicago
Chicago

United States, Indiana
MediSphere Medical Research Center, LLC
Evansville

United States, Indiana
Indiana University
Indianapolis

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

United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge

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
Henry Ford Medical Center - New Center One
Novi

United States, Minnesota
University of Minnesota Medical Center
Minneapolis

United States, Minnesota
Mayo Clinic
Rochester

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 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, North Carolina
PMG Research of Charlotte LLC
Charlotte

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
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
Allergy, Asthma and Immunology Center, PC
Tulsa

United States, Oklahoma
Central States Research, LLC
Tulsa

United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia

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

United States, Texas
Centex Studies, Inc.
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
San Antonio Gastroenterology
San Antonio

United States, Texas
Baylor Scott and White Health
Temple

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
Carilion Clinic
Roanoke

United States, Wisconsin
Franciscan Skemp Healthcare
La Crosse

Australia, New South Wales
Liverpool Hospital
Liverpool

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

Australia, Queensland
Coastal Digestive Health
Maroorchydore

Australia, Queensland
University of the Sunshine Coast
North Mackay

Australia, Queensland
Mater Hospital Brisbane
South Brisbane

Australia, South Australia
Flinders Medical Centre
Bedford Park

Australia, Victoria
Monash Medical Centre
Clayton

Australia, Victoria
St Vincent's Hospital Melbourne
Fitzroy

Australia, Western Australia
St John of God Subiaco Hospital
Subiaco

Austria
Medical University Innsbruck
Innsbruck

Austria
University Hospital St. Poelten
St Polten

Austria
Medical University Vienna
Vienna

Bulgaria
MHAT Ruse AD
Ruse

Bulgaria
Excelsior Medical Center
Sofia

Bulgaria
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
Sofia

Bulgaria
Diagnostic and Consulting Center Alexandrovska
Sofia

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

Canada, Alberta
West Edmonton Gastroenterology Consultants
Edmonton

Canada, British Columbia
Fraser Clinical Trials Inc.
New Westminister

Canada, British Columbia
GI Research Institute
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
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
Peking University First Hospital
Beijing

China
Peking University People's Hospital
Beijing

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

China
The Seventh Medical Center of PLA General Hospital
Beijing

China
First Hospital of Jilin University
Changchun

China
Guangzhou First People's Hospital
Guangzhou Shi

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

China
Anhui Provincial Hospital
Hefei

China
The First Affiliated Hospital of Nanchang University
Nanchang

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

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

China
China Medical University Hospital
Taichung City

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

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Helsinki University Central Hospital (HUCH)
Helsinki

France
Centre Hospitalier de Blois
Blois Cedex

France
Beziers Hospital
Béziers

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
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
JSC Evex Medical Corporation - Oncology Center
Kutaisi

Georgia
Helsicore - Israeli Georgian Medical Research Clinic
Tbilisi

Georgia
LLC Vivamedi
Tbilisi

Georgia
Tbilisi State Medical University
Tbilisi

Georgia
LTD Institute of Clinical Cardiology
Tbilisi

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

Georgia
LTD Academician N.Kipshidze Central University Clinic
Tbilisi

Georgia
LTD Aversi Clinic
Tbilisi

Georgia
LTD MediClub Georgia
Tbilisi

Georgia
David Tatishvili Medical Center
Tbilisi

Georgia
JSC Evex Medical Corporation - Telavi Referral Hospital
Telavi

Germany
Gastroenterological Special Practice at Wittenbergplatz
Berlin

Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin

Germany
Charite - Universitätsmedizin Berlin
Berlin

Germany
Hospital Waldfriede e.V.
Berlin

Germany
Brandenburg City Hospital
Brandenburg an der Havel

Germany
Medical Care Unit Dachau
Dachau

Germany
Klinikum Darmstadt
Darmstadt

Germany
Kliniken Essen-Mitte
Essen

Germany
Johann Wolfgang Goethe University Hospital
Frankfurt am Main

Germany
Studiengesellschaft BSF
Halle

Germany
University Hospital Halle (Saale)
Halle

Germany
Asklepios Klinik Hamburg
Hamburg

Germany
Universitatsklinikum Schleswig-Holstein
Keil

Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz

Germany
University Hospital Muenster
Muenster

Germany
Universitaetsklinikum Charite - Ruppiner Kliniken GmbH
Neuruppin

Germany
Robert-Bosch-Hospital
Stuttgart

Greece
Laiko General Hospital of Athens
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

Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Bekescsaba

Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest

Hungary
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar
Budapest

Hungary
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat
Gyor

Hungary
CRU Hungary Kft
Miskolc

Hungary
Kanizsai Dorottya Hospital
Nagykanizsa

Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar

Hungary
Clinfan Ltd
Szekszárd

Hungary
Csongrad County Dr. Bugyi Istvan Hospital
Szentes

Hungary
Zala Megyei KorhazHaematologia
Zalaegerszeg

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

Israel
Asaf Harofeh Medical Center
Beer Jacob

Israel
Rambam Health Care Campus
Haifa

Israel
Clalit Health Services
Jerusalem

Israel
Meir Medical Center
Kfar-Saba

Israel
Rabin Medical Center
Petah Tikva

Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv

Korea, Republic of
Pusan National University Hospital
Busan

Korea, Republic of
Inje University Haeundae Paik Hospital
Busan

Korea, Republic of
Yeungnam University Medical Center
Daegu

Korea, Republic of
Seoul National University Hospital
Seoul

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
Vilnius University Hospital Santariskes Clinics
Vilnius

Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius

Lithuania
Vilnius City Clinical Hospital
Vilnius

Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam

Netherlands
Academisch Medisch Centrum
Amsterdam

Netherlands
UMC Groningen
Groningen

Netherlands
Radboud University Medical Center
Nijmegen

Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen

Netherlands
St. Elisabeth Ziekenhuis
Tilburg

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

Poland
Nicolaus Copernicus Hospital
Gdansk

Poland
Private Medical Practice Miroslaw Fic
Jelenia Gora

Poland
BioVirtus Medical Centre
Jozefow

Poland
Centrum Opieki Zdrowotnej Orkan Med
Ksawerow

Poland
LUX MED Centrum Medyczne - Lodz
Lodz

Poland
Polish Mother's Memorial Hospital - Research Institute
Lodz

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
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC
Szczecin

Poland
WIP Warsaw IBD Point
Warsaw

Poland
PRIMA LCC Specialist Clinics
Warsaw

Poland
Children's Memorial Health Institute
Warsaw

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

Poland
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
Wierzchoslawice

Poland
LUX MED Centrum Medyczne - Wroclaw
Wroclaw

Poland
Wroclaw Medical University
Wroclaw

Poland
Jan Mikulicz Radecki University Hospital
Wroclaw

Poland
Clinical Research Center Early-Phase Research Facility
Wroclaw

Poland
LexMedica
Wroclaw

Poland
Ars Medica
Wroclaw

Poland
EMC Medical Institute S.A
Wroclaw

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

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

Portugal
Hospital Beatriz Angelo
Loures

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

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

Russian Federation
Territorial Clinical Hospital
Barnaul

Russian Federation
Regional Clinical Hospital #3
Chelyabinsk

Russian Federation
Chelyabinsk Regional Clinical Hospital
Chelyabinsk

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

Russian Federation
Immanuel Kant Baltic Federal University
Kaliningrad

Russian Federation
Kaluga Regional Hospital
Kaluga

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

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

Russian Federation
City Clinical Hospital 24
Moscow

Russian Federation
CJSC Nasledniki
Moscow

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

Russian Federation
Railway Station Clinical Hospital
Nizhny Novgorod

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

Russian Federation
Medical University REAVIZ
Samara

Russian Federation
Regional Clinical Hospital
Saratov

Russian Federation
Sochi City Hospital No 5
Sochi

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
State Unitary Enterprise Passengeravtotrans
St. Petersburg

Russian Federation
Medical Center Eko-Bezopasnost LLC
St. Petersburg

Russian Federation
Tomsk Regional Clinical Hospital
Tomsk

Russian Federation
G.G. Kuvatov Republican Clinical Hospital
Ufa

Russian Federation
Medical Scientific Manufacturing Association Dvizheniye Clinic
Volgograd

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

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

Serbia
Clinical Hospital Center Zvezdara Clinic of Internal Diseases
Belgrade

Serbia
Military Medical Academy, Clinic of Gastroenterology and Hepatology
Belgrade

Serbia
Clinical Center Kragujevac
Kragujevac

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

Serbia
General Hospital Pancevo
Pancevo

Serbia
General Hospital Djordje Jovanovic Zrenjanin
Zrenjanin

Slovakia
Cliniq, s.r.o.
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
Gastromedic s.r.o.
Nove Zamky

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

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

Slovenia
General Hospital Celje
Celje

South Africa
Ahmed Kathrada Private Hospital
Gauteng

South Africa
Emmed Research
Pretoria

Spain
Teknon Medical Center
Barcelona

Spain
University Hospital Reina Sofia
Cordoba

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
University Hospital Puerta de Hierro Majadajonda
Majadahonda, Madrid

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

Taiwan
National Cheng Kung University Hospital
Tainan, Taiana

Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan City

Taiwan
Taipei Veterans General Hospital
Tapei, Beitou Dist.

Taiwan
National Taiwan University Hospital
Tapei

Turkey
Hacettepe Universitesi
Ankara

Turkey
Firat University Medical Faculty
Elazig

Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul

Turkey
Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi
Istanbul

Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
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
Kharkiv City Clinical Hospital 2
Kharkiv

Ukraine
Khmelnytskyi Regional Hospital
Khmelnytskyi

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
Kyiv Regional Clinical Hospital
Kyiv

Ukraine
Volyn Regional Clinical Hospital
Lutsk

Ukraine
Lviv Regional Clinical Hospital
Lviv

Ukraine
Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department
Odesa

Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia

Ukraine
Health Clinic, LLC
Vinnytsya

Ukraine
Multidisciplinary Clinic of the St. Nicholas, LLC
Zaporizhia

Ukraine
Zaporizhzhya Regional
Zaporizhzhya

Sponsors and Collaborators

Celgene

Investigators

Study Director: Kanthi Kollengode, MD Celgene Corporation

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: March 3, 2021
  • Last Verified: February 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: RPC01-3202
    RPC01
    Severely active
    Moderately active
    Ozanimod
    Oral
    Crohn Disease
    Crohn's Disease
  • Additional relevant MeSH terms: Crohn Disease