A Phase 3 Multicenter Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

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A Phase 3 Multicenter Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Brief description of study

The purpose of this study is to see whether ozanimod (RPC1063), (also referred to as the ‘study drug’), is safe and how well it works as a possible treatment of moderate to severe ulcerative colitis (UC). UC is a chronic inflammatory disorder of the bowels. People with UC suffer from diarrhea, rectal bleeding, weight loss, abdominal pain, and fever. The study drug is an investigational drug, which means that it is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of UC. The study drug is a chemical compound that is thought to act on the immune system by making certain types of white blood cells (lymphocytes, including T cells) stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation and, in turn, reducing symptoms of UC. The study drug has already been tested in humans and has shown some evidence of being safe and effective.

Clinical Study Identifier: s18-00517

ClinicalTrials.gov Identifier: NCT02531126

Principal Investigator: David P Hudesman.

Other Investigator: Shannon Chang.

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