Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

NCT Number	NCT06456593
Lead Sponsor	Abivax S.A.
Conditions	Moderately to Severely Active Crohn Disease
Enrollment	212 participants
Start Date	2024-10-30
Primary Completion	2026-12 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-04-27