Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Colitis, Ulcerative, Ulcerative Colitis, Ozanimod, Pediatric

Eligibility

You can join if…

Open to people ages 2-17

  • 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 CAN'T join 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
  • Other protocol-defined inclusion/exclusion criteria apply

Locations

  • University of California Davis Health accepting new patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Local Institution - 0052 completed
    Garden Grove California 92845 United States
  • Lucile Packard Children's Hospital not yet accepting patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT05076175
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated