Clinical Trial

Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)

Recruiting Phase 2
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Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.
Protocol Amendment History 1 change
notable Trial sites expanded: 24 -> 28 locations 2026-04-01
Trial Details
NCT Number NCT07265570
Lead Sponsor InSilico Medicine Hong Kong Limited
Conditions Ulcerative Colitis
Enrollment 80 participants
Start Date 2025-12-10
Primary Completion 2027-08-15 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-01