A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
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.
• 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 \<18 years of age who has assented to participate in the study, or as required per local regulations).
• In countries not allowing females of childbearing potential (FOCBP) to participate without an acceptable contraceptive method, the FOCBP must agree to abide to local requirements and eg, use at least an acceptable method of contraception until the end of treatment.