A Phase 1b/2a, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MB-001 in Participants With Moderately to Severely Active Ulcerative Colitis

Condition studied

Ulcerative Colitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence of adverse events (AEs), treatment emergent AEs (TEAEs), serious AEs, AEs of special interest, and treatment discontinuation due to TEAEs through Week 12, Changes in clinical laboratory parameters, physical examination findings, and vital signs through Week 12, Proportion of participants achieving clinical remission, defined by a modified Mayo Score (mMS) ≤ 2 with a Mayo endoscopic subscore (MES) ≤ 1, rectal bleeding (RB) subscore of 0, and stool frequency (SF) subscore ≤ 1, at Week 12

Endpoint detail

Proportion of participants achieving endoscopic improvement, defined as an MES ≤ 1, at Week 12, Proportion of participants achieving endoscopic remission, defined as an MES = 0, at Week 12, Proportion of participants achieving mMS clinical response, defined as a reduction from Baseline ≥ 2 points and ≥ 30% in mMS, with a reduction ≥ 1 in RB subscore or absolute RB subscore ≤ 1, at Week 12, Proportion of participants achieving symptomatic remission, defined as a SF subscore of 0 and an RB subscore of 0, at Week 12, Proportion of participants achieving histologic remission, defined as a Geboes Score  2B.0, at Week 12, Proportion of participants achieving histologic remission, defined as Robarts Histopathology Index ≤ 3 with subscores of 0 for lamina propria neutrophils, neutrophils in the epithelium, and erosions/ulcers, at Week 12, Proportion of participants achieving histologic endoscopic mucosal improvement, defined as a Geboes Score ≤ 3.1 and MES ≤ 1, at Week 12, Proportion of participants achieving mucosal healing, defined as a Geboes Score ≤ 2B.1 and MES ≤ 1, at Week 12