drugset / Trial / NCT07296315
Confirmatory Clinical Study in Active Ulcerative Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MH002 | Other / unclassified | 1e+10 unknown | Oral |
| Subject | MH002 | Other / unclassified | 4e+10 unknown | Oral |