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

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.

Timeline

Start

2024-10-30

Primary completion

2026-12

Completion

2028-04

Drugs

Indications