A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trial status: Authorised Proportion of participants who achieve clinical remission defined as 3‑component MMCS ≤2 (SFS ≤1, RBS = 0, and MES ≤1) at Week X, Proportion of participants who have a clinical response per 3 component MMCS (defined as a decrease from baseline of ≥2 points and ≥30%, and either a decrease in RBS of ≥1 point or an absolute RBS of 0 or 1) at Week X, Proportion of participants who achieve clinical remission per MMCS at Week X Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs, Changes in clinical laboratory parameters, electrocardiogram parameters, and vital signs, Change from baseline in 3-component modified Mayo Clinic Score (MMCS) (defined as sum of stool frequency subscore [SFS], rectal bleeding subscore [RBS], and Mayo endoscopic subscores [MES]a) at Week X

Proportion of participants who achieve clinical remission defined as 3‑component MMCS ≤2 (SFS ≤1, RBS = 0, and MES ≤1) at Week X, Proportion of participants who have a clinical response per 3 component MMCS (defined as a decrease from baseline of ≥2 points and ≥30%, and either a decrease in RBS of ≥1 point or an absolute RBS of 0 or 1) at Week X, Proportion of participants who achieve clinical remission per MMCS at Week X

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 70 participants