Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease

Crohn Disease Clinical Trial

Official title: A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid Treatment

Status Not yet recruiting

Clinical Trial Summary

This Phase IIa study is a 16-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe active Crohn's Disease who have inadequate response, loss of response, or intolerance to prior amino-salicylates, immunosuppressant treatment, biologics, and/or corticosteroid treatment, and followed by a 4 weeks period of follow-up after the last study drug intake.

Clinical Trial Description

This Phase 2a study is a 16-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe active Crohn's Disease who have inadequate response, loss of response, or intolerance to prior amino-salicylates, immunosuppressant treatment, biologics, and/or corticosteroid treatment, and followed by a 4 weeks period of follow-up after the last study drug intake.

Eligible patients will be randomized according to a 2/1 ratio in two different groups of treatment : ABX464 50mg OR placebo.

After the treatment phase at week 16, all randomized patients willing to continue with the study treatment will have the possibility to enter a separate open-label study. In that case, patients will stop their participation after week 16, otherwise they will go through the 4 weeks follow-up period and the end of study visit will take place on week 20. ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT03905109
• Study type: Interventional
• Source: Abivax S.A.
• Contact: Paul GINESTE, PhD
• Phone: +33 1 53 83 09 61
• Email: paul.gineste@abivax.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 15, 2020
• Completion date: October 30, 2021