RECRUITING

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

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Conditions

Colitis, UlcerativeUlcerative ColitisOzanimodPediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-05-30
Study Completion:2031-08-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05076175

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.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
  2. * Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
  3. * 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
  1. * Diagnosis of Crohn's disease or indeterminate colitis
  2. * Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
  3. * Apheresis within 2 weeks of randomization
  4. * History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

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
Local Institution - 0096
Sacramento, California, 95817
United States
Local Institution - 0007
Hartford, Connecticut, 06106
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Local Institution - 0075
Orlando, Florida, 32803
United States
Local Institution - 0016
Atlanta, Georgia, 30342
United States
University of Iowa
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
Local Institution - 0095
Worcester, Massachusetts, 01655
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
United States
Washington University
Saint 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
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
MultiCare Health System
Tacoma, Washington, 98405
United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-30
Study Completion Date2031-08-14

Study Record Updates

Study Start Date2022-05-30
Study Completion Date2031-08-14

Terms related to this study

Keywords Provided by Researchers

  • Ulcerative Colitis
  • Ozanimod
  • Pediatric

Additional Relevant MeSH Terms

  • Colitis, Ulcerative