RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
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
About This Trial
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.
Who May Be Eligible (Plain English)
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 weakened immune system, or participants with known genetic disorders as a cause for colitis
- Other protocol-defined inclusion/exclusion criteria apply
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Ozanimod
Specified dose on specified days
Locations (20)
Local Institution - 0041
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Local Institution - 0052
Garden Grove, California, United States
Loma Linda University Health System
Loma Linda, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Local Institution - 0096
Sacramento, California, United States
Local Institution - 0007
Hartford, Connecticut, United States
Local Institution - 0064
Washington D.C., District of Columbia, United States
Local Institution - 0075
Orlando, Florida, United States
Local Institution - 0016
Atlanta, Georgia, United States
Local Institution - 0101
Park Ridge, Illinois, United States
Local Institution - 0100
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Maine Medical Partners
Portland, Maine, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Local Institution - 0042
Springfield, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States