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.
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
Parallel
Ozanimod
DrugSpecified dose on specified days
Proportion of participants who achieve clinical remission
Proportion of participants who achieve clinical remission
Proportion of participants who achieve clinical response
Proportion of participants who achieve clinical response
Proportion of participants who achieve symptomatic remission
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