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.
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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

Jean-Michel Muhlinghaus, DVM

+32 9 277 08 50

clinicaltrials@mrmhealth.com

CONTACT

Carmen Fleurinck, MD

+32 9 277 08 50

CONTACT