Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients

Summary

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit

Timeline

Start

2022-09-19

Primary completion

2022-09-19

Completion

2022-09-19

Outcome

Outcome not reported

Stopped: “Study design revised and to be found under new NCT06456593 ABX464-202”

Drugs

Indications