Confirmatory Clinical Study in Active Ulcerative Colitis
Recruiting
Phase 2
Interventional Study
Colitis, Ulcerative
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 204 (estimated)
- Sponsor
- MRM Health NV · Industry
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.
* Diagnosis of active mild-to-moderate UC at Screening as defined by an mMS of 4 to 7, including a MES ≥2 (confirmed by …
Contacts
Carmen Fleurinck, MD
+32 9 277 08 50
CONTACT