Clinical Trial

A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis

Not Yet Recruiting Phase 2
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Summary
This Phase IIa, multicenter, single-arm trial evaluates the efficacy, safety, tolerability, and pharmacokinetics of PTT-621 tablets in adults (18-70 years) with moderate-to-severe active ulcerative colitis (UC) who have inadequate response/intolerance to standard therapies. Participants receive PTT-621 for 12 weeks. The primary endpoint is the proportion of participants achieving endoscopic improvement at Week 12. Secondary endpoints include safety, clinical remission, clinical response, symptom response, pharmacokinetics, and inflammatory biomarkers. The study is sponsored by Pyrotech Therapeutics, with ethical approval from Renji Hospital's IRB.
Trial Details
NCT Number NCT07747155
Lead Sponsor Pyrotech Therapeutics, Inc.
Conditions Ulcerative Colitis (UC)
Enrollment 40 participants
Start Date 2026-08
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-07