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Recruiting
NCT07296315
Confirmatory Clinical Study in Active Ulcerative Colitis
Conditions: Colitis, Ulcerative
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 204
Sponsor: MRM Health NV
Location: ARA Professionals Miami Florida
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.
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 central reading), a Mayo Rectal Bleeding score of 1 or 2, and a Mayo Stool Frequency score ≥1.
* UC lesions extending ≥10 cm from the anal verge.
* Participant must either receive a stable dose of orally administered 5-aminosalicylic acid (5-ASA); have failed, due to insufficient efficacy, oral 5-ASA; have a documented intolerance or poor tolerance to an aminosalicylic acid treatment, including 5-ASA, or be contra-indicated to receive 5-ASA treatment per local labeling.
* Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant \
Source: ClinicalTrials.gov (NCT07296315). StuddyBuddy aggregates publicly available trial information.