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NCT05076175PHASE2, PHASE3Recruiting

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

Bristol-Myers Squibb

Start Date

5/30/2022

Completion Date

7/12/2032

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 Criteria

Age Range: 2 years to 17 years

Inclusion Criteria * 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 Exclusion Criteria * 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 * Other protocol-defined inclusion/exclusion criteria apply

Interventions

DRUG

Ozanimod

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Conditions

Colitis, Ulcerative

Locations

Local Institution - 0041

Phoenix, Arizona 85016-7710

United States

University of Arizona

Tucson, Arizona 85724

United States

Local Institution - 0052

Garden Grove, California 92845

United States

Loma Linda University Health System

Loma Linda, California 92354

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Lucile Packard Children's Hospital

Palo Alto, California 94304

United States

University of California Davis Health

Sacramento, California 95817

United States

Local Institution - 0007

Hartford, Connecticut 06106

United States

Local Institution - 0064

Washington D.C., District of Columbia 20010

United States

Local Institution - 0075

Orlando, Florida 32803

United States

Local Institution - 0016

Atlanta, Georgia 30342

United States

Local Institution - 0101

Park Ridge, Illinois 60068

United States

Local Institution - 0100

Indianapolis, Indiana 46202

United States

Local Institution - 0049

Iowa City, Iowa 52242

United States

Maine Medical Partners

Portland, Maine 04102

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Local Institution - 0042

Springfield, Massachusetts 01199

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Local Institution - 0093

Detroit, Michigan 48201

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

Washington University

St Louis, Missouri 63110

United States

Local Institution - 0028

New York, New York 10029

United States

Columbia University Medical Center

New York, New York 10032

United States

Local Institution - 0023

New York, New York 10065

United States

University of North Carolina Medical Center

Chapel Hill, North Carolina 27599

United States

Local Institution - 0047

Charlotte, North Carolina 28203

United States

Cleveland Clinic

Cleveland, Ohio 44124

United States

Local Institution - 0062

Oklahoma City, Oklahoma 73112

United States

Local Institution - 0045

Hershey, Pennsylvania 17033

United States

Local Institution - 0099

Charleston, South Carolina 29425

United States

Local Institution - 0103

Fort Worth, Texas 76104

United States

Texas Children's Hospital

Houston, Texas 77030

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Local Institution - 0091

Seattle, Washington 98122

United States

MultiCare Health System

Tacoma, Washington 98405

United States

Local Institution - 0037

Milwaukee, Wisconsin 53226

United States

The Children's Hospital at Westmead

Westmead, New South Wales 2145

Australia

Monash Health

Clayton, Victoria 3168

Australia

Local Institution - 0086

Murdoch, Western Australia 6150

Australia

Local Institution - 0076

Brussels, Bruxelles-Capitale, Région de 1090

Belgium

UZ Leuven

Leuven, Vlaams-Brabant 3000

Belgium

Local Institution - 0056

Brussels, 1090

Belgium

Local Institution - 0063

Edegem, 2650

Belgium

Centre Hospitalier Régional de la Citadelle

Liège, 4000

Belgium

Local Institution - 0071

Liège, 4000

Belgium

Local Institution - 0083

Hamilton, Ontario L8N 3Z5

Canada

Local Institution - 0104

Toronto, Ontario M3M 0B2

Canada

Local Institution - 0082

Toronto, Ontario M5G 1X8

Canada

CHU de Toulouse - Hôpital des Enfants

Toulouse, Haute-Garonne 31059

France

Local Institution - 0022

Bron, 69500

France

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, 14033

France

Local Institution - 0017

Paris, 75015

France

Local Institution - 0073

Paris, 75571

France

Local Institution - 0032

München, Bavaria 80337

Germany

Universitätsklinikum Leipzig

Leipzig, Saxony 04103

Germany

Local Institution - 0031

Dresden, 01307

Germany

Schneider Children's Medical Center

Petah Tikva, Central District 49202

Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem 9013102

Israel

Rambam Health Care Campus

Haifa, Northern District 3109601

Israel

Aichi Children's Health and Medical Center

Ōbu, Aichi-ken 474-8710

Japan

Kurume University Hospital

Kurume-shi, Fukuoka 8300011

Japan

Komatsu Municipal Hospital

Komatsu, Ishikawa-ken 923-8560

Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa 2300012

Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka 569-8686

Japan

Institute of Science Tokyo Hospital

Bunkyo-Ku, Tokyo 113-8519

Japan

National Center for Child Health and Development

Setagaya-ku, Tokyo 1578535

Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo 160-0023

Japan

Hiroshima University Hospital

Hiroshima, 734-8551

Japan

Juntendo University Hospital

Tokyo, 113-8431

Japan

Local Institution - 0084

Krakow, Lesser Poland Voivodeship 30-663

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship 50-369

Poland

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship 00-728

Poland

Centrum Zdrowia Dziecka w Warszawie

Warsaw, Masovian Voivodeship 04-746

Poland

Local Institution - 0015

Rzeszów, Podkarpackie Voivodeship 35-302

Poland

Local Institution - 0013

Gdansk, Pomeranian Voivodeship 80-803

Poland

Local Institution - 0079

Gdansk, Pomeranian Voivodeship 80-803

Poland

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship 71-434

Poland

Local Institution - 0092

Lodz, Łódź Voivodeship 91-738

Poland

Clinical Research Puerto Rico

San Juan, 00909-1711

Puerto Rico

Local Institution

Moscow, 119991

Russia

Local Institution

Moskva, 119571

Russia

Local Institution - 0048

Badalona, Barcelona [Barcelona] 08916

Spain

Local Institution - 0051

Esplugues de Llobregat, Barcelona [Barcelona] 08950

Spain

Local Institution - 0044

Madrid, Madrid, Comunidad de 28009

Spain

Local Institution - 0057

Madrid, 28007

Spain

Local Institution - 0050

Madrid, 28046

Spain

Birmingham Children's Hospital

Birmingham, England B4 6NH

United Kingdom

King's College Hospital

London, Greater London SE5 9RS

United Kingdom

Local Institution - 0105

London, Greater London SW10 9NH

United Kingdom

Barts Health NHS Trust

London, London, City of E1 1BB

United Kingdom