NCT03093259

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFα, Vedolizumab and/or Corticosteroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This Phase IIa study is an 8-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 Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

Detailed description

This Phase IIa study is an 8-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 Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period. Eligible subjects will be randomized according to a 2/1 ratio in two different groups of treatment. Randomized subjects who will receive 50 mg ABX464 orally once daily for 56 days.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	ABX464	ABX464 is a new Anti-inflammatory drug
DRUG	Placebo oral capsule	Placebo matching with ABX464

Timeline

• Start date: 2017-11-16
• Primary completion: 2018-07-25
• Completion: 2019-02-04
• First posted: 2017-03-28
• Last updated: 2024-06-03
• Results posted: 2023-02-08

Locations

19 sites across 8 countries: Austria, Belgium, Czechia, France, Germany, Hungary, Poland, Spain