A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis

The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks. Researchers will compare MB-001 to placebo to investigate its effects on clinical symptoms as well as endoscopic and histopathological findings. Patients will be offered open-label extension for another 12 weeks following the double-blind, placebo-controlled part of the study. Participants will keep a daily diary to record their symptoms and will have up to nine clinic visits.

NCT Number	NCT07374471
Lead Sponsor	Mage Biologics
Conditions	Ulcerative Colitis (UC)
Enrollment	100 participants
Start Date	2026-04-01
Primary Completion	2028-07 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-04-14