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

Description

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.

Conditions

Colitis, Ulcerative

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Colitis, Ulcerative
Intervention / Treatment

-

Contacts and Locations

Phoenix

Local Institution - 0041, Phoenix, Arizona, United States, 85016-7710

Tucson

University of Arizona, Tucson, Arizona, United States, 85724

Garden Grove

Local Institution - 0052, Garden Grove, California, United States, 92845

Loma Linda

Loma Linda University Health System, Loma Linda, California, United States, 92354

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Palo Alto

Lucile Packard Children's Hospital, Palo Alto, California, United States, 94304

Sacramento

Local Institution - 0096, Sacramento, California, United States, 95817

Hartford

Local Institution - 0007, Hartford, Connecticut, United States, 06106

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Orlando

Local Institution - 0075, Orlando, Florida, United States, 32803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-08-14