drugset / Trial / NCT03093259

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

NCT03093259

Phase 2 Completed 32 enrolled Abivax S.A.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-11-16
Primary completion
2018-07-25
Completion
2019-02-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Obefazimod Small molecule 50 mg Oral

Indications