A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Recruiting · NCT05076175 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 23 US states.
- 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
- University of California Davis Health - 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
- Local Institution - 0049 - 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
- Local Institution - 0093 - Detroit, Michigan, United States
- Mayo Clinic in Rochester, Minnesota - Rochester, Minnesota, United States
- Washington University - St Louis, Missouri, United States
- Local Institution - 0028 - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Local Institution - 0023 - New York, New York, United States
- University of North Carolina Medical Center - Chapel Hill, North Carolina, United States
- Local Institution - 0047 - Charlotte, North Carolina, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Local Institution - 0062 - Oklahoma City, Oklahoma, United States
- Local Institution - 0045 - Hershey, Pennsylvania, United States
- Local Institution - 0099 - Charleston, South Carolina, United States
- Local Institution - 0103 - Fort Worth, Texas, United States
- Texas Children's Hospital - Houston, Texas, United States
- Seattle Children's Hospital - Seattle, Washington, United States
- Local Institution - 0091 - Seattle, Washington, United States
- MultiCare Health System - Tacoma, Washington, United States
- Local Institution - 0037 - Milwaukee, Wisconsin, United States
- Local Institution - 0022 - Bron, France
- Local Institution - 0056 - Brussels, Belgium
- Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre - Caen, France
- Local Institution - 0031 - Dresden, Germany
- Local Institution - 0063 - Edegem, Belgium
- Hiroshima University Hospital - Hiroshima, Japan
- Centre Hospitalier Régional de la Citadelle - Liège, Belgium
- Local Institution - 0071 - Liège, Belgium
- Local Institution - 0057 - Madrid, Spain
- Local Institution - 0050 - Madrid, Spain
- Local Institution - Moscow, Russia
- Local Institution - Moskva, Russia
- Local Institution - 0017 - Paris, France
- Local Institution - 0073 - Paris, France
- Clinical Research Puerto Rico - San Juan, Puerto Rico
- Juntendo University Hospital - Tokyo, Japan
- Aichi Children's Health and Medical Center - Ōbu, Aichi-ken, Japan
- Local Institution - 0048 - Badalona, Barcelona [Barcelona], Spain
- Local Institution - 0051 - Esplugues de Llobregat, Barcelona [Barcelona], Spain
- Local Institution - 0032 - München, Bavaria, Germany
- Local Institution - 0076 - Brussels, Bruxelles-Capitale, Région de, Belgium
- Schneider Children's Medical Center - Petah Tikva, Central District, Israel
- Birmingham Children's Hospital - Birmingham, England, United Kingdom
- Kurume University Hospital - Kurume-shi, Fukuoka, Japan
Showing 60 of 90 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →