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Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

  • Clinicaltrials.gov identifier

    NCT03440372

  • Recruitment Status

    Recruiting

  • First Posted

    February 22, 2018

  • Last update posted

    March 2, 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 #1 - 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: February 2018
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: September 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 at week 12 [ 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% at week 12. [ 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 at week 12 [ 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
Holland Center for Family Health
Peoria

United States, Arizona
Elite Clinical Studies, LLC
Phoenix

United States, Arkansas
Arkansas Gastroenterology, P.A.
North Little Rock

United States, California
Sharp Chula Vista Medical Center
Chula Vista

United States, California
Valley View Internal Medicine
Garden Grove

United States, California
San Diego Clinical Trials
La Mesa

United States, California
Children's Hospital of Los Angeles
Los Angeles

United States, California
Gastrointestinal Biosciences
Los Angeles

United States, California
VA Northern California Health Care System
Mather

United States, California
ABS Health, LLC
Mission Viejo

United States, California
Alliance Clinical Research
Oceanside

United States, California
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto

United States, California
Inland Empire Liver Foundation
Rialto

United States, California
Medical Associates Research Group
San Diego

United States, Colorado
Childrens Hospital Colorado
Aurora

United States, Connecticut
Yale University
New Haven

United States, Florida
Gastro Florida
Clearwater

United States, Florida
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza
Gainesville

United States, Florida
Qway Research LLC
Hialeah

United States, Florida
Floridian Clinical Research LLC
Hialeah

United States, Florida
Harmony Medical Research Institute
Hialeah

United States, Florida
The Center for Gastrointestinal Disorders
Hollywood

United States, Florida
Vista Health Research
Homestead

United States, Florida
Florida Center for Gastroenterology
Largo

United States, Florida
Nova Clinical Research Center LLC
Miami

United States, Florida
LCC Medical Research Institute, LLC
Miami

United States, Florida
Research Associates of South Florida LLC
Miami

United States, Florida
Advanced Research for Health Improvement
Naples

United States, Florida
NSB Research
New Smyrna Beach

United States, Florida
HMD Research LLC
Orlando

United States, Florida
Advanced Medical Research Center
Port Orange

United States, Florida
Asclepes Research Centers
Weeki Wachee

United States, Georgia
Consultative Gastroenterology
Atlanta

United States, Georgia
Atlanta Gastroenterology Associates, LLC
Atlanta

United States, Georgia
Children's Center for Digestive Healthcare
Atlanta

United States, Georgia
Gastrointestinal Disease Research
Columbus

United States, Georgia
Gastroenterology Associates Of Central Georgia LLC
Macon

United States, Illinois
Rush University Medical Center - University Cardiovascular Surgeons
Chicago

United States, Illinois
Northwestern University
Chicago

United States, Illinois
Carle Foundation Hospital
Urbana

United States, Iowa
Iowa Digestive Disease Center
Clive

United States, Kentucky
University of Kentucky Health Care
Lexington

United States, Louisiana
CroNOLA LLC
Houma

United States, Louisiana
Centex Studies, Inc.
Lake Charles

United States, Louisiana
Nola Research Works
New Orleans

United States, Louisiana
LSU Health Sciences Center Shreveport
Shreveport

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore

United States, Maryland
Digestive Disease Associates, PA
Catonsville

United States, Maryland
Woodholme Gastroenterology Associates
Glen Burnie

United States, Massachusetts
Brigham and Women's Hospital - Crohn's and Colitis Center
Chestnut Hill

United States, Massachusetts
Baystate Medical Center
Springfield

United States, Michigan
Medex Research Institute
Caro

United States, Michigan
Revive Research Institute
Southfield

United States, Mississippi
Southern Therapy and Advanced Research
Jackson

United States, Missouri
Washington University School of Medicine
Saint Louis

United States, New Jersey
Englewood Hospital and Medical Center
Englewood

United States, New Mexico
University of New Mexico Hospital
Albuquerque

United States, New York
Advantage Clinical Trials
Bronx

United States, New York
NY Scientific
Brooklyn

United States, New York
Adirondack Medical Research Center
Glens Falls

United States, New York
Northwell Health
Great Neck

United States, New York
Cornell University
New York

United States, New York
Lenox Hill Hospital
New York

United States, New York
Circuit Clinical
Orchard Park

United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville

United States, North Carolina
Carolinas HealthCare System Digestive Health
Charlotte

United States, North Carolina
Internal Medicine Research
Charlotte

United States, North Carolina
Carolina Research Center
Greenville

United States, Ohio
Great Lakes Medical Research, LLC
Beachwood

United States, Ohio
Cleveland Clinic - Taussig Cancer Institute
Cleveland

United States, Ohio
Great Lakes Gastroenterology
Mentor

United States, Ohio
Great Lakes Medical Research, LLC
Warren

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City

United States, Oklahoma
Digestive Disease Specialists
Oklahoma City

United States, Oregon
Oregon Health & Science University
Portland

United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey

United States, Pennsylvania
Penn State University Milton S Hershey Medical Center
State College

United States, Tennessee
Quality Medical Research
Nashville

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Tennessee
Advanced Gastroenterology
Union City

United States, Texas
Avant Research Associates, LLC - Austin
Austin

United States, Texas
Baylor College of Medicine
Houston

United States, Texas
Houston Methodist Hospital
Houston

United States, Texas
Biopharma Informatic Inc. Research Center
Houston

United States, Texas
GI Specialists of Houston
Houston

United States, Texas
Premier Vein and Vascular Center
Houston

United States, Texas
Sun Research Institute
San Antonio

United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake

United States, Texas
Digestive Health Specialists of Tyler
Tyler

United States, Utah
University of Utah School of Medicine
Salt Lake City

United States, Virginia
Gastroenterology Associates, PC
Gainesville

United States, Virginia
Summit Clinical Research, LLC
Petersburg

United States, Virginia
Virginia Gastroenterology Institute PC
Suffolk

United States, Washington
University of Washington Medical Center
Seattle

United States, Washington
Dermatologist Specialists of Spokane
Spokane

United States, Wisconsin
Aurora Health Care Aurora Research
Grafton

Argentina
Sanatorio Guemes
Ciudad Autonoma de Buenos Aires

Argentina
Hospital Privado Centro Medico de Cordoba
Cordoba

Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario

Argentina
Universidad Nacional De Rosario - Hospital Provincial Del Centenario
Rosario

Argentina
Sanatorio 9 de Julio - CICE 9 de Julio
San Miguel de Tucuman

Australia, New South Wales
Concord Repatriation General Hospital
Concord

Australia, New South Wales
Nepean Hospital
Kingswood

Australia, New South Wales
Wollongong Hospital
Wollongong

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, South Australia
The Queen Elizabeth Hospital
Woodville South

Australia, Western Australia
Harry Perkins Medical Research Institute, Fiona Stanley Hospital
Murdoch

Australia
Ballarat Base Hospital
Ballarat

Belarus
Grodno City Clinical Hospital #4
Grodno

Belarus
Vitebsk Regional Clinical Specialized Center
Vitebsk

Belgium
Algemeen Ziekenhuis Klina
Brasschaat

Belgium
Universitair Ziekenhuis Brussel
Brussels

Belgium
University Hospital Brussels
Brussels

Belgium
CHU Saint-Luc
Brussels

Belgium
Queen Fabiola Children's University Hospital
Brussels

Belgium
Universitair Ziehenhuis Antwerpen
Edegem

Belgium
Universitair Ziekenhuis Gent
Ghent

Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven

Belgium
Clinique du Montlegia
Liege

Belgium
Sart Tilman Hospital Department of Gastroenterology and Hepatology
Seraing

Belgium
Hospital Centre of Walloon Picarde
Tournai

Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
Banja Luka

Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar

Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo

Bosnia and Herzegovina
General Hospital "Prim.dr. Abdulah Nakas"
Sarajevo

Bulgaria
Multiprofile Hospital for Active Treatment Medline
Plovdiv

Bulgaria
Second MHAT Sofia AD
Sofia

Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia

Bulgaria
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
Sofia

Bulgaria
ACIBADEM City Clinic Medical Center Bregalnitsa
Varna

Canada, Alberta
University of Calgary Health - The Gastrointestinal Research Group (GIRG)
Calgary

Canada, British Columbia
Okanagan Clinical Trials Ltd
Kelowna

Canada, British Columbia
Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre
Vancouver

Canada, Manitoba
Winnipeg Clinic Dermatology Research
Winnipeg

Canada, Nova Scotia
Viable Clinical Research
Bridgewater

Canada, Ontario
London Health Sciences Centre, University Hospital
London

Canada, Ontario
LHSC Victoria Hospital
London

Canada, Ontario
Toronto Digestive Disease Associates Inc
Vaughan

Croatia
Clinical Hospital Center Osijek
Osijek

Croatia
Clinical Hospital Centre Rijeka
Rijeka

Croatia
Clinical Hospital Center Split
Split

Croatia
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
Zagreb

Croatia
Clinical Hospital Dubrava
Zagreb

Croatia
University Hospital Centre Zagreb, Clinic of Internal Diseases
Zagreb

Czechia
Military Hospital Brno
Brno

Czechia
St. Anne's University Hospital Brno
Brno

Czechia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové

Czechia
Soukroma Gastroenterologicka ambulance a endoskopie
Most

Czechia
PreventaMed
Olomouc

Czechia
Krajská nemocnice Pardubice, Kožní oddelení
Pardubice

Czechia
University Hospital Pilsen
Plzen

Czechia
University Hospital Motol
Prague 5

Czechia
ISCARE, a.s.
Prague 9

Czechia
Institut klinicke a experimentalni mediciny
Praha 4

Denmark
Bispebjerg Hospital
Copenhagen

Denmark
Holbaek Hospital
Holbaek

Denmark
Nykobing F Hospital
Nykobing F

Finland
Turku University Hospital
Turku

France
CHU Amiens Picardie - Site Sud
Amiens cedex 1

France
Centre Hospitalier Intercommunal de Creteil
Creteil Cedex

France
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon Cedex

France
CHU de Grenoble Alpes
Grenoble Cedex 9

France
CHRU de Lille - Hopital Claude Huriez
Lillie Cedex

France
Hopital Nord
Marseille cedex 20

France
Hospital Pontchaillou
Rennes

France
CHU de Rouen Hopital Charles Nicolle
Rouen Cedex

France
CHU de Toulouse Hopital Rangueil
Toulouse Cedex 09

Germany
Charite - Universitaetsmedizin Berlin
Berlin

Germany
Gastroenterology Am Bayerischen Platz
Berlin

Germany
DRK Clinics Berlin
Berlin

Germany
Agaplesion Markus Krankenhaus
Frankfurt

Germany
Interdisciplinary Crohn Colitis Center Rhein Main
Frankfurt

Germany
University Hospital Hamburg-Eppendorf
Hamburg

Germany
Universitaetsklinikum Leipzig AoeR
Leipzig

Germany
Practice for Gastroenterology and Internal Medicine
Ludwigshafen am Rhein

Germany
St Marien und St Annastiftskrankenhaus
Ludwigshafen am Rhein

Germany
Synesis Research Center
Munich

Germany
Universitaetsklinikum Tuebingen
Tuebingen

Germany
Universitaetsklinikum Ulm
Ulm

Ireland, Dublin
St Vincent's University Hospital
Dublin 4

Ireland
Beaumont Hospital
Dublin 9

Israel
Bat Yamon Medical Center, Clalit Medical Services
Bat Yam

Israel
Shaare Zedek Medical Center
Jerusalem

Israel
Galilee Medical Center
Nahariya

Israel
Chaim Sheba Medical Center
Ramat Gan

Israel
Kaplan Medical Center
Rechovot

Italy
University Polyclinic Hospital of Bari
Bari

Italy
Polyclinic S. Orsola-Malpighi
Bologna

Italy
Civil Hospital of Brescia
Brescia

Italy
Poliambulanza Hospital
Brescia

Italy
IRCCS "Savario De Bellis"
Castellana Grotte

Italy
University Hospital Mater Domini
Catanzaro

Italy
"Ss. Annunziata" Policlinic of Chieti
Chieti

Italy
University Polyclinic Hospital G. Martino
Messina

Italy
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milano

Italy
Humanitas Research Hospital - Humanitas Mirasole S.p.A
Milan

Italy
Azienda Socio Sanitaria Territoriale (ASST) di Monza
Monza

Italy
Hospital of Di Padova
Padova

Italy
United Hospitals Villa Sofia Cervello
Palermo

Italy
Polyclinic San Matteo IRCCS
Pavia

Italy
Polyclinic Tor Vergata
Roma

Italy
Univerisity Polyclinic Foundation Agostino Gemelli
Roma

Italy
Azienda Ospedaliera San Camillo Forlanini
Rome

Italy
Integrated University Hospital Santa Maria della Misericordia of Udine
Udine

Italy
A.O. Universitaria Fondazione Macchi
Varese

Italy
Sacred Heart Don Calabria
Verona

Korea, Republic of
Korea University Medical Center - Korea University Ansan Hospital
Ansan

Korea, Republic of
Hanyang University Guri Hospital
Guri-si

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si

Korea, Republic of
Severance Hospital
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Korea, Republic of
Kangbuk Samsung Hospital
Seoul

Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul

Latvia
P. Stradins Clinical University Hospital
Riga

Latvia
Digestive Diseases Center Gastro
Riga

Latvia
Riga East Clinical University Hospital clinic Gailezers
Riga

Mexico, Jalisco
Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.
Zapapan

Mexico, Nuevo León
Centro Regiomontano de Estudios Clinicos Roma SC.
Monterrey

Mexico, Nuevo León
Instituto Tecnológico y de Estudios Superiores de Monterrey
Monterrey

Mexico, Querétaro
SMIQ
Santiago de Queretaro

Mexico
Hospital Christus Muquerza del Parque S.A. de C.V.
Chihuahua

Mexico
Centro de Investigacion Clinica Acelerada (CICA) S.C.
Mexico

Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan

Moldova, Republic of
"Sfanta Treime" Clinical Municipal Hospital
Chisinau

Moldova, Republic of
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
Chisinau

Moldova, Republic of
"Sf. Arhanghel Mihail" Municipal Clinical Hospital
Chisinau

Moldova, Republic of
Republican Clinical Hospital, Department of Colorectal Surgery
Chisinau

Moldova, Republic of
Republican Clinical Hospital
Chisinau

Norway
Akershus University Hospital
Lørenskog

Norway
Lovisenberg Diakonale Sykehus
Oslo

Poland
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok

Poland
Medical Services Center MaxMed
Bochnia

Poland
Nzoz All-Medicus
Katowice

Poland
Kornel Gibinski Independent Public Central Clinical Hospital in Katowice
Katowice

Poland
GLOBE Clinical Research Sp. z o.o. LLC
Klodzko

Poland
PLEJADY Sp. z o.o. (LLC) Medical Centre
Krakow

Poland
Landa Specialist Doctor's Offices
Krakow

Poland
Krakow Medical Center LLC
Krakow

Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz

Poland
Salve Limited Liability Company Limited Partnership, Outpatient Clinic
Lodz

Poland
1 Military Clinical Hospital in Lublin
Lublin

Poland
Provincial Specialist Hospital in Olsztyn
Olsztyn

Poland
SOLUMED Medical Center
Poznan

Poland
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
Torun

Poland
H-T. Medical Center Sp. z o.o. LLC Limited Partnership
Tychy

Poland
Polimedica
Ul. Piotrkowska 177

Poland
Maternal Pediatric and Adolescent Healthcare Centre
Warsaw

Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
Warszawa

Romania
Hyperclinica MedLife Grivita
Bucharest

Romania
Center of Diagnosis and Treatment Provita
Bucharest

Romania
Fundeni Clinical Institute
Bucharest

Romania
Bucharest University Emergency Hospital, Department of Internal Medicine II
Bucharest

Romania
Dr. Carol Davila Central Military Emergency Clinical Hospital
Bucharest

Romania
Craiova County Emergency Clinical Hospital
Craiova

Romania
Colentina Clinical Hospital
Napoca

Romania
Targu Mures County Emergency Clinical Hospital
Targu Mures

Russian Federation
Chita State Medical Academy
Chita

Russian Federation
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk

Russian Federation
City Clinical Hospital No 7 - Kazan
Kazan

Russian Federation
Regional Clinical Hospital
Khanty-mansiysk

Russian Federation
Federal Siberian Research and Clinical Center
Krasnoyarsk

Russian Federation
Moscow Clinical Scientific and Practical Center
Moscow

Russian Federation
Novosibirskiy Gastrocenter
Novosibirsk

Russian Federation
Republican Hospital na VA Baranov
Petrozavodsk

Russian Federation
Evromedservis
Pushkin

Russian Federation
Clinic UZI 4D, LLC
Pyatigorsk

Russian Federation
Pyatigorsk City Hospital 2
Pyatigorsk

Russian Federation
Rostov State Medical University
Rostov-on-Don

Russian Federation
Medical Center Reavita Med Spb LLC
Saint Petersburg

Russian Federation
Samara Station Railway Clinical Hospital under OAO Russian Railways
Samara

Russian Federation
S.M. Kirov Military Medical Academy
St Petersburg

Russian Federation
Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office
St. Petersburg

Russian Federation
SPb SBIH City Hospital of Saint Martyr Elizaveta
St. Petersburg

Russian Federation
Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital
Surgut

Russian Federation
Tula Regional Clinical Hospital
Tula

Russian Federation
City Clinical Hospital #21
Ufa

Russian Federation
Ulyanovsk Regional Clinical Hospital
Ulyanovsk

Russian Federation
Novgorod Regional Clinical Hospital
Veliky Novgorod

Russian Federation
Regional Clinical Hospital
Vladimir

Russian Federation
Primorsky Regional Clinical Hospital No.1
Vladivostok

Russian Federation
Medical Center of Far-Eastern Federal University
Vladivostok

Saudi Arabia
King Fahad Specialist Hospital
Dammam

Saudi Arabia
King Abdul Aziz University Hospital
Jeddah

Saudi Arabia
King Saud Medical Complex
Riyadh

Saudi Arabia
King Fahad National Guard Hospital
Riyadh

Spain
General University Hospital of Alicante
Alicante

Spain
University Hospital Germans Trias i Pujol
Badalona

Spain
University Hospital of the Canary Islands (HUC) La Laguna
La Laguna

Spain
University Hospital de La Princesa
Madrid

Spain
University Hospital La Paz
Madrid

Spain
University Hospital Virgen Macarena
Sevilla

Spain
University Hospital Virgen del Rocio
Sevilla

Spain
Viladecans Hospital
Viladecans

Switzerland
Lindenhofspital
Bern

Switzerland
Cantonal Hospital Saint Gallen
St.Gallen

Switzerland
University Hospital Zurich
Zurich

Taiwan
Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi
Kozlu

Turkey
Ankara University Medical Faculty Cebeci Hospital
Ankara

Turkey
Uludag Universitesi Tip Fakultesi
Bursa

Turkey
Bezmialem Foundation University Medical Faculty
Istanbul

Turkey
Marmara University
Istanbul

Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadiköy/Istanbul

Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon

Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi

Ukraine
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Dnipropetrovsk

Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk

Ukraine
V.T. Zaitsev Institute of General and Emergency Surgery
Kharkiv

Ukraine
Kyiv City Clinical Hospital #18
Kyiv

Ukraine
Medical Center Consilium Medical
Kyiv

Ukraine
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC
Kyiv

Ukraine
Kyiv Regional Hospital #2
Kyiv

Ukraine
Kyiv Regional Clinical Hospital
Kyiv

Ukraine
Public City Clinical Hospital of Emergency Medical Care
Lviv

Ukraine
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council
Poltava

Ukraine
Ternopil City Public Emergency Medical Care Hospital
Ternopil

Ukraine
Vinnytsia City Clinical Hospital #1
Vinnytsia

Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia

Ukraine
First Private Clinic
Zhytomyr

United Kingdom
Bristol Royal Infirmary
Bristol

United Kingdom
Ulster Hospital
Dundonald

United Kingdom
Queen Elizabeth University Hospital
Glasgow

United Kingdom
Victoria Hospital Blackpool
Lancashire Blackpool

United Kingdom
Royal London Hospital
London

United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London

United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London

United Kingdom
John Radcliffe Hospital
Oxford

United Kingdom
Royal Shrewsbury Hospital
Shrewsbury

United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton

United Kingdom
Torbay Hospital
Torquay

Sponsors and Collaborators

Celgene

Investigators

Study Director: Kanthi Kollengode, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03440372 History of Changes
  • Other Study ID Numbers: RPC01-3201, U1111-1203-7225, 2017-004292-31
  • First Posted: February 22, 2018 Key Record Dates
  • Last Update Posted: March 2, 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: RPC01-3201
    Crohn Disease
    Crohn's Disease
    RPC01
    Ozanimod
    Moderately active
    Severely active
    Oral
  • Additional relevant MeSH terms: Crohn Disease