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241 active trials for Crohn Disease

The Efficacy and Safety of Oral Etrasimod as Therapy for Moderately to Severely Active Crohn's Disease

Objectives: Primary Objectives Substudy A - Phase 2 To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn's disease (CD) Substudy 1 - Phase 2b To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active CD To select an oral etrasimod dose(s), based on efficacy and safety, for continued development Substudy 2 - Induction (Phase 3) To evaluate the efficacy of the selected etrasimod dose versus placebo as induction therapy in subjects with moderately to severely active CD Substudy 3 - Maintenance (Phase 3) To evaluate the efficacy of etrasimod versus placebo as maintenance therapy in subjects with moderately to severely active CD Substudy 4 - Long-Term Extension To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to severely active CD Secondary Objectives Substudy A - Phase 2 To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active CD To evaluate the pharmacokinetic (PK) and pharmacodynamic effects of etrasimod as induction and maintenance therapy, including changes in lymphocytes, C-reactive protein (CRP), and fecal calprotectin (FCP) in subjects with moderately to severely active CDSubstudy 1 - Phase 2b To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active CD To provide a subset of the target study population, etrasimod responders, to be evaluated in Substudy 3 - Maintenance Substudy 2 - Induction (Phase 3) To evaluate the safety and tolerability of the selected etrasimod Phase 3 dose (3 mg or 2 mg) versus placebo as induction therapy in subjects with moderately to severely active CD To provide a subset of the target study population, etrasimod responders, to be evaluated in Substudy 3 - Maintenance Substudy 3 - Maintenance (Phase 3) To evaluate the efficacy of etrasimod on sustained clinical remission and endoscopic response, endoscopic remission, and corticosteroid-free clinical remission in subjects with moderately to severely active CD To characterize the safety and tolerability of etrasimod as maintenance therapy in subjects with moderately to severely active CD Substudy 4 - Long-Term Extension To evaluate the long-term efficacy of etrasimod in subjects with moderately to severely active CD

Start: September 2021