drugset / Trial / NCT07296315

Confirmatory Clinical Study in Active Ulcerative Colitis

NCT07296315 ↗

Phase 2 Recruiting 204 enrolled MRM Health NV
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-04-03
Primary completion
2027-09
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject MH002 Other / unclassified 1e+10 unknown Oral
Subject MH002 Other / unclassified 4e+10 unknown Oral

Indications