NCT06109441

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: AltruBio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, a Maintenance Phase, and an OLE.

Detailed description

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, a Maintenance Phase, and an OLE. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of the initial Screening Visit. 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. 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 unless they continue in an open-label extension (OLE).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	ALTB-268	ALTB-268 drug product (DP) for SC injection is supplied as a sterile and preservative-free frozen solution or lyophilized powder. All excipients used in the DP formulation are of multi-compendial quality and have precedence for use in parenteral products.

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-04-01
• Completion: 2027-03-01
• First posted: 2023-10-31
• Last updated: 2026-01-02

Locations

24 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study