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Clinical trial

ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

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Last updated:30th Aug 2023
Identifier: NCT05507203
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 ID: NCT05507203

Sponsor: Abivax S.A.
Information provided by: Abivax S.A. (Responsible Party)
Last Update Posted: 2023-08-31

Brief Summary:

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Drug: ABX464
Drug: Placebo

Category Value
Study Start (Actual) 2022-10-10
Primary Completion (Estimated)
Study Completion (Estimated) 2024-06
Enrollment (Estimated) 612
Study Type Interventional
Phase Phase 3
Other Study ID Numbers

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