NCT05076175
Not yet recruiting
October 13, 2021
October 13, 2021
Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in causing 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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Ozanimod High Dose |
Drug: Ozanimod Specified dose on specified days |
Experimental: Ozanimod Low Dose |
Drug: Ozanimod Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
United States, Georgia
Local Institution
Atlanta
France
Local Institution
Paris
Japan, Tokyo
Local Institution
Bunkyo-ku
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb