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First received: October 06, 2023

Clinical Trial: Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

Study Status: Completed

Recruit Status: RECRUITING

Condition: Ulcerative Colitis

Study Type: INTERVENTIONAL


Official Title: Phase 2a, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of ALTB-268 in Subjects With Moderately to Severely Active Ulcerative Colitis Refractory to Biologic Therapy

Brief Summary: ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC.The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase.Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks.Primary efficacy endpoint will be evaluated at week 12.Week 12 dosing will occur during the 40 wks Maintenance Phase.During 40…

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