NCT07374471

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

A Phase 1b/2a, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MB-001 in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mage Biologics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This double-blind, placebo controlled clinical trial is intended to study the effects of oral MB-001 in patients with moderately to severely active ulcerative colitis. The primary objectives of the study are to assess safety and efficacy. Secondary and exploratory endpoints are endoscopic response, histological response, pharmacokinetics, and pharmacodynamic changes compared to baseline.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
BIOLOGICAL	MB-001	oral capsule formulation
BIOLOGICAL	Matching placebo to MB-001	oral capsule formulation

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-07-01
• Completion: 2028-08-01
• First posted: 2026-01-28
• Last updated: 2026-04-14

Locations

1 site across 1 country: Moldova