Phase 1b2a Study of Oral MB-001 Capsules for Treating Moderate to Severe Ulcerative Colitis

What this Trial Is About

Researchers are evaluating MB-001, an oral biologic medication, as a treatment for adults with moderately to severely active ulcerative colitis. This double-blind, placebo-controlled clinical trial aims to assess the safety and effectiveness of MB-001 compared to a matching placebo. The study also investigates endoscopic and histological responses, as well as pharmacokinetics and pharmacodynamic changes. The trial is sponsored by Mage Biologics and includes participants aged 18 to 75 years. Participants will take either MB-001 or a matching placebo capsule once daily for 12 weeks during the double-blind phase. Following this, those completing the initial phase may enter an open-label extension lasting another 12 weeks where all participants receive the active treatment. The study includes up to nine clinic visits and daily symptom diaries to monitor the participants condition throughout the treatment and extension phases. During the study, participants will undergo clinical symptom evaluations, laboratory tests, and endoscopic examinations to measure outcomes such as clinical remission, endoscopic improvement, and histologic remission. Researchers will monitor adverse events and laboratory parameters like blood cell counts and liver function until four weeks after treatment ends. The total involvement for participants can last up to 24 weeks, including both study phases and follow-up assessments.

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