Ulcerative Colitis Clinical Trial
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
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 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.
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. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of SV1. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268. followed by a weekly maintenance dose of ALTB-268 in the 12 week Induction Study Phase. During the Induction Phase, study participants will be evaluated weekly at V0 (Day 1), V1 (Week 1), V2 (Week 2), V3 (Week 3), V4 (Week 4), V5 (Week 5), V6 (Week 6), V7 (Week 7), V8(Week 8), V9 (Week 9), V10 (Week 10), and V11 (Week 11) and V12 (Week 12; End of Induction Phase). Participants entering the maintenance study phase will continue to receive the SC dose of ALTB-268 every two weeks, up to week 52. Upon completion of the maintenance study phase, study participants will be asked to return for an end of study visit in approximately 4 weeks, for end of study visit. ;
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