RecruitingPhase 2Phase 3NCT05076175

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

A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

Sponsor

Bristol-Myers Squibb

Enrollment

120 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

Colitis Ulcerative

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an oral medication called ozanimod in children and teenagers with moderate to severe ulcerative colitis (a chronic inflammatory bowel disease causing colon inflammation and bleeding). **You may be eligible if...** - You are a child or teenager with moderately to severely active ulcerative colitis - Your colitis extends beyond the rectum (confirmed by a camera exam) - You have tried and failed, lost response to, or cannot tolerate at least one standard treatment such as steroids, aminosalicylates, immunosuppressants, or biologics **You may NOT be eligible if...** - You have Crohn's disease or indeterminate colitis - You have a C. difficile bacterial infection - You have had a procedure to remove blood from the gut (apheresis) in the past 2 weeks - You have a known immune system disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOzanimod

Specified dose on specified days

Locations(90)

Local Institution - 0041

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Local Institution - 0052

Garden Grove, California, United States

Loma Linda University Health System

Loma Linda, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

Local Institution - 0096

Sacramento, California, United States

Local Institution - 0007

Hartford, Connecticut, United States

Local Institution - 0064

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

Local Institution - 0075

Orlando, Florida, United States

Local Institution - 0016

Atlanta, Georgia, United States

Local Institution - 0101

Park Ridge, Illinois, United States

Local Institution - 0100

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Maine Medical Partners

Portland, Maine, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Local Institution - 0042

Springfield, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Local Institution - 0028

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Local Institution - 0023

New York, New York, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Local Institution - 0047

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Local Institution - 0062

Oklahoma City, Oklahoma, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Local Institution - 0099

Charleston, South Carolina, United States

Local Institution - 0103

Fort Worth, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Local Institution - 0091

Seattle, Washington, United States

MultiCare Health System

Tacoma, Washington, United States

Children's Wisconsin

Milwaukee, Wisconsin, United States

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Local Institution - 0086

Murdoch, Western Australia, Australia

Local Institution - 0076

Brussels, Bruxelles-Capitale, Région de, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Local Institution - 0056

Brussels, Belgium

Local Institution - 0063

Edegem, Belgium

Centre Hospitalier Régional de la Citadelle

Liège, Belgium

Local Institution - 0071

Liège, Belgium

Local Institution - 0083

Hamilton, Ontario, Canada

Local Institution - 0104

Toronto, Ontario, Canada

Local Institution - 0082

Toronto, Ontario, Canada

CHU de Toulouse - Hôpital des Enfants

Toulouse, Haute-Garonne, France

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, France

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, France

Hôpital Universitaire Necker Enfants Malades

Paris, France

Local Institution - 0073

Paris, France

Local Institution - 0032

München, Bavaria, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Schneider Children's Medical Center

Petah Tikva, Central District, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Rambam Health Care Campus

Haifa, Northern District, Israel

Aichi Children's Health and Medical Center

Ōbu, Aichi-ken, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Komatsu Municipal Hospital

Komatsu, Ishikawa-ken, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Institute of Science Tokyo Hospital

Bunkyo-Ku, Tokyo, Japan

National Center for Child Health and Development

Setagaya-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Hiroshima University Hospital

Hiroshima, Japan

Juntendo University Hospital

Tokyo, Japan

Local Institution - 0084

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, Poland

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, Poland

Centrum Zdrowia Dziecka w Warszawie

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0015

Rzeszów, Podkarpackie Voivodeship, Poland

Local Institution - 0013

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0079

Gdansk, Pomeranian Voivodeship, Poland

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, Poland

Local Institution - 0092

Lodz, Łódź Voivodeship, Poland

Clinical Research Puerto Rico

San Juan, Puerto Rico

Local Institution

Moscow, Russia

Local Institution

Moskva, Russia

Local Institution - 0048

Badalona, Barcelona [Barcelona], Spain

Local Institution - 0051

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Local Institution - 0044

Madrid, Madrid, Comunidad de, Spain

Local Institution - 0057

Madrid, Spain

Local Institution - 0050

Madrid, Spain

Birmingham Children's Hospital

Birmingham, England, United Kingdom

King's College Hospital

London, Greater London, United Kingdom

Local Institution - 0105

London, Greater London, United Kingdom

Barts Health NHS Trust

London, London, City of, United Kingdom

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NCT05076175

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