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

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

  • Colitis, Ulcerative

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 5367696, California 5332921 92354
Contact:
Kalyan Ray Parashette, Site 0087
505-274-0704

Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Contact:
Shervin Rabizadeh, Site 0074
310-423-7100

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Dawn Ebach, Site 0049
319-471-1301

Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Athos Bousvaros, Site 0005
617-699-1021

University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Basavaraj Kerur, Site 0095
774-441-8082

Children's Hospital of Michigan
Detroit 4990729, Michigan 5001836 48201
Contact:
Kristen Cares, Site 0093
586-909-8958

Mayo Clinic in Rochester, Minnesota
Rochester 5043473, Minnesota 5037779 55905
Contact:
Michael Stephens, Site 0070
111111

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Charles Samson, Site 0053
513-518-8949

Columbia University Medical Center
New York 5128581, New York 5128638 10032
Contact:
JOSEPH PICORARO, Site 0040
212-305-5903

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44124
Contact:
Jessica Barry, Site 0036
216444231

Penn State Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Stefany Garrity, Site 0045
508-523-1571

Texas Children's Hospital
Houston 4699066, Texas 4736286 77030
Contact:
Lina Karam, Site 0067
832-822-3612

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Contact:
Ghassan Wahbeh, Site 0060
111111

MultiCare Health System
Tacoma 5812944, Washington 5815135 98405
Contact:
Raghu Varier, Site 0046
503-847-4748

Children's Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Abdul Elkadri, Site 0037
414-266-3282

More Details

NCT ID
NCT05076175
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Children's National Health System, based in Washington, DC, is Magnet® designated and is consistently ranked among the top pediatric hospitals.