NCT07296315

Confirmatory Clinical Study in Active Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: MRM Health NV · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Low-dose MH002	Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 1 × 10\^10 equivalent colony forming units \[eqCFU\]), administered orally (in a capsule) once daily
DRUG	High-dose MH002	Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 4 × 10\^10 equivalent colony forming units \[eqCFU\]), administered orally (in a capsule) once daily
DRUG	Placebo	Blank placebo administered orally (in a capsule) once daily

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2028-05-01
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study