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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ozanimod High Dose
  • Drug: Ozanimod
    Specified dose on specified days
    Other names:
    • RPC1063
Experimental
Ozanimod Low Dose
  • Drug: Ozanimod
    Specified dose on specified days
    Other names:
    • RPC1063

Recruiting Locations

Loma Linda University Health System
Loma Linda, California 92354
Contact:
Kalyan Ray Parashette, Site 0087
505-274-0704

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Shervin Rabizadeh, Site 0074
310-423-7100

University of California Davis Health
Sacramento, California 95817
Contact:
Trinh Truong, Site 0096
310-597-1251

University of Iowa
Iowa City, Iowa 52242
Contact:
Dawn Ebach, Site 0049
319-471-1301

Boston Children's Hospital
Boston, Massachusetts 02115
Contact:
Athos Bousvaros, Site 0005
617-699-1021

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
Contact:
Basavaraj Kerur, Site 0095
774-441-8082

Children's Hospital of Michigan
Detroit, Michigan 48201
Contact:
Kristen Cares, Site 0093
586-909-8958

Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Contact:
Michael Stephens, Site 0070
111111

Washington University
St Louis, Missouri 63110
Contact:
Charles Samson, Site 0053
513-518-8949

Columbia University Medical Center
New York, New York 10032
Contact:
JOSEPH PICORARO, Site 0040
212-305-5903

Cleveland Clinic
Cleveland, Ohio 44124
Contact:
Jessica Barry, Site 0036
216444231

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Contact:
Stefany Garrity, Site 0045
508-523-1571

Texas Children's Hospital
Houston, Texas 77030
Contact:
Lina Karam, Site 0067
832-822-3612

Seattle Children's Hospital
Seattle, Washington 98105
Contact:
Ghassan Wahbeh, Site 0060
111111

MultiCare Health System
Tacoma, Washington 98405
Contact:
Raghu Varier, Site 0046
503-847-4748

Children's Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Abdul Elkadri, Site 0037
414-266-3282

Clinical Research Puerto Rico
San Juan, Puerto Rico 00909-1711
Contact:
Antonio Del Valle-Segarra, Site 0098
787-723-5945

More Details

NCT ID
NCT05076175
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center