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First received: September 07, 2022

Clinical Trial: ABTECT - Maintenance

Study Status: Completed

Recruit Status: RECRUITING

Condition: Ulcerative Colitis

Study Type: INTERVENTIONAL


Official Title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severe

Brief Summary: This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy 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),…

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