NCT06456593

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

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Moderately to Severely Active Crohn Disease

Interventions

Type	Name	Description
DRUG	Obefazimod	Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
OTHER	Placebo	Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).

Timeline

• Start date: 2024-10-30
• Primary completion: 2026-12-01
• Completion: 2028-04-01
• First posted: 2024-06-13
• Last updated: 2025-09-18

Locations

149 sites across 12 countries: United States, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain

Regulatory

• FDA-regulated drug study