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Oral Ozanimod Efficacy and Safety Results from Phase 2 TOUCHSTONE Extension Trial in Patients with Ulcerative Colitis Presented

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TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1 mg doses of ozanimod compared with placebo after eight weeks of treatment (induction phase) in 197 patients with moderate to severe active ulcerative colitis. Patients who achieved a clinical response at week 8 continued with their original treatment through week 32 in a maintenance phase. The primary endpoint was the proportion of patients in remission at week 8. Secondary endpoints were: the proportion of patients achieving a clinical response, the proportion of patients with mucosal improvement and the change from baseline in Mayo score. Previously reported results showed TOUCHSTONE met its primary endpoint and secondary endpoints with statistical significance for patients on the 1 mg dose of ozanimod versus placebo.TOUCHSTONE participants in all three treatment arms entered the open-label extension if they did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase (170 of the 197 patients). The objective of the open-label extension phase is to evaluate the long-term efficacy and safety of daily ozanimod 1 mg.
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Occurred on:
Oct 17, 2016
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Related Keywords Ulcerative Colitis, Touchstone, Ozanimod