A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IM047-0012023-509248-86
• Study Type: interventional
• Target: 120
• Locations: 13 countries
• Sites: 90

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative Colitis; Ozanimod; Pediatric

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve clinical remission

  At Week 52

Secondary Outcomes (14)

• Proportion of participants who achieve clinical remission

  At Week 10

• Proportion of participants who achieve clinical response

  At Week 52

• Proportion of participants who achieve clinical response

  At Week 10

• Proportion of participants who achieve symptomatic remission

  At Week 10 and Week 52

• Time to achievement of symptomatic remission

  Up to 6 years

Study Arms (2)

Ozanimod High Dose

EXPERIMENTAL

Drug: Ozanimod

Ozanimod Low Dose

EXPERIMENTAL

Drug: Ozanimod

Interventions

Ozanimod DRUG

Specified dose on specified days

Also known as: RPC1063

Ozanimod High Dose; Ozanimod Low Dose

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
• Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
• Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

You may not qualify if:

• Diagnosis of Crohn's disease or indeterminate colitis
• Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
• Apheresis within 2 weeks of randomization
• History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (90)

Local Institution - 0041

Phoenix, Arizona, 85016-7710, United States

WITHDRAWN

University of Arizona

Tucson, Arizona, 85724, United States

WITHDRAWN

Local Institution - 0052

Garden Grove, California, 92845, United States

COMPLETED

Loma Linda University Health System

Loma Linda, California, 92354, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

NOT YET RECRUITING

University of California Davis Health

Sacramento, California, 95817, United States

RECRUITING

Local Institution - 0007

Hartford, Connecticut, 06106, United States

COMPLETED

Local Institution - 0064

Washington D.C., District of Columbia, 20010, United States

COMPLETED

Local Institution - 0075

Orlando, Florida, 32803, United States

COMPLETED

Local Institution - 0016

Atlanta, Georgia, 30342, United States

COMPLETED

Local Institution - 0101

Park Ridge, Illinois, 60068, United States

NOT YET RECRUITING

Local Institution - 0100

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Maine Medical Partners

Portland, Maine, 04102, United States

NOT YET RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Local Institution - 0042

Springfield, Massachusetts, 01199, United States

COMPLETED

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Local Institution - 0028

New York, New York, 10029, United States

COMPLETED

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Local Institution - 0023

New York, New York, 10065, United States

WITHDRAWN

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27599, United States

WITHDRAWN

Local Institution - 0047

Charlotte, North Carolina, 28203, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44124, United States

RECRUITING

Local Institution - 0062

Oklahoma City, Oklahoma, 73112, United States

WITHDRAWN

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Local Institution - 0099

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Local Institution - 0103

Fort Worth, Texas, 76104, United States

NOT YET RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Local Institution - 0091

Seattle, Washington, 98122, United States

COMPLETED

MultiCare Health System

Tacoma, Washington, 98405, United States

RECRUITING

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Local Institution - 0086

Murdoch, Western Australia, 6150, Australia

WITHDRAWN

Local Institution - 0076

Brussels, Bruxelles-Capitale, Région de, 1090, Belgium

WITHDRAWN

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Local Institution - 0056

Brussels, 1090, Belgium

COMPLETED

Local Institution - 0063

Edegem, 2650, Belgium

NOT YET RECRUITING

Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

RECRUITING

Local Institution - 0071

Liège, 4000, Belgium

WITHDRAWN

Local Institution - 0083

Hamilton, Ontario, L8N 3Z5, Canada

WITHDRAWN

Local Institution - 0104

Toronto, Ontario, M3M 0B2, Canada

NOT YET RECRUITING

Local Institution - 0082

Toronto, Ontario, M5G 1X8, Canada

NOT YET RECRUITING

CHU de Toulouse - Hôpital des Enfants

Toulouse, Haute-Garonne, 31059, France

RECRUITING

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, 69500, France

RECRUITING

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, 14033, France

RECRUITING

Hôpital Universitaire Necker Enfants Malades

Paris, 75015, France

RECRUITING

Local Institution - 0073

Paris, 75571, France

WITHDRAWN

Local Institution - 0032

München, Bavaria, 80337, Germany

COMPLETED

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Schneider Children's Medical Center

Petah Tikva, Central District, 49202, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 9013102, Israel

RECRUITING

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

RECRUITING

Aichi Children's Health and Medical Center

Ōbu, Aichi-ken, 474-8710, Japan

RECRUITING

Kurume University Hospital

Kurume-shi, Fukuoka, 8300011, Japan

RECRUITING

Komatsu Municipal Hospital

Komatsu, Ishikawa-ken, 923-8560, Japan

RECRUITING

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 2300012, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

Institute of Science Tokyo Hospital

Bunkyo-Ku, Tokyo, 113-8519, Japan

RECRUITING

National Center for Child Health and Development

Setagaya-ku, Tokyo, 1578535, Japan

RECRUITING

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

RECRUITING

Juntendo University Hospital

Tokyo, 113-8431, Japan

RECRUITING

Local Institution - 0084

Krakow, Lesser Poland Voivodeship, 30-663, Poland

WITHDRAWN

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, 50-369, Poland

RECRUITING

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, 00-728, Poland

RECRUITING

Centrum Zdrowia Dziecka w Warszawie

Warsaw, Masovian Voivodeship, 04-746, Poland

RECRUITING

Local Institution - 0015

Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

WITHDRAWN

Local Institution - 0013

Gdansk, Pomeranian Voivodeship, 80-803, Poland

WITHDRAWN

Local Institution - 0079

Gdansk, Pomeranian Voivodeship, 80-803, Poland

WITHDRAWN

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, 71-434, Poland

RECRUITING

Local Institution - 0092

Lodz, Łódź Voivodeship, 91-738, Poland

COMPLETED

Clinical Research Puerto Rico

San Juan, 00909-1711, Puerto Rico

RECRUITING

Local Institution

Moscow, 119991, Russia

WITHDRAWN

Local Institution

Moskva, 119571, Russia

WITHDRAWN

Local Institution - 0048

Badalona, Barcelona [Barcelona], 08916, Spain

COMPLETED

Local Institution - 0051

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

COMPLETED

Local Institution - 0044

Madrid, Madrid, Comunidad de, 28009, Spain

COMPLETED

Local Institution - 0057

Madrid, 28007, Spain

COMPLETED

Local Institution - 0050

Madrid, 28046, Spain

WITHDRAWN

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

RECRUITING

King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

RECRUITING

Local Institution - 0105

London, Greater London, SW10 9NH, United Kingdom

NOT YET RECRUITING

Barts Health NHS Trust

London, London, City of, E1 1BB, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 13, 2021
• Study Start: May 30, 2022
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): August 14, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (36); ES (5); FR (5); JP (10); RU (2); PL (9); BE (6); PR (1); GB (4); CA (3); DE (3); IL (3); AU (3)