A Multicenter Randomized Double-Blind Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn s Disease

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A Multicenter Randomized Double-Blind Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn s Disease

Brief description of study

This is a seamless Phase 2/3, multicenter, randomized, double-blind, study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of etrasimod as therapy in subjects with moderately to severely active CD who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). Subjects who are refractory or intolerant to corticosteroids and/or immunosuppressants may be either previously exposed to or naïve to biologics.

Clinical Study Identifier: s21-00122

ClinicalTrials.gov Identifier: NCT04173273

Principal Investigator: David P Hudesman.

Other Investigators: Adam Faye, Ariela Holmer, Simon J Hong, Jordan E Axelrad, Shannon Chang.

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