The Efficacy and Safety of Oral Etrasimod as Therapy for Moderately to Severely Active Crohn's Disease
Status:
Not yet recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
Summary
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