Conditions: Ulcerative Colitis
Keywords: ABX464 Ulcerative Colitis Refractory
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Subjects will receive 50 mg of ABX464 orally once daily for 56 days. arm 2: Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.

Interventions: intervention 1: ABX464 intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: ABX464 is a new Anti-inflammatory drug intervention 2: Placebo matching with ABX464

Protocol document:
Prot_000.pdf: 







































































































SAP_001.pdf: