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

Condition studied

Ulcerative Colitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from baseline in centrally-assessed Mayo endoscopic subscore (MES) at Week 12

Endpoint detail

1. Clinical remission at Week 12, defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and a Rectal Bleeding (RB) subscore of 0, and an SF subscore not greater than baseline, with endoscopic MES based on worst segment assessed by a blinded central reader, and 2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data, 2. Change from baseline in histologic scores at Week 12 (Robarts’ Histopathology Index [RHI]), 3. (Median) Percent change from baseline in fecal calprotectin (FC) at Week 12, 4. Change from baseline in UC-100 score at Week 12, 5. Change from baseline in PRO-2 at Week 12, 6. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 7. Treatment-emergent abnormalities in laboratory parameters and vital signs