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A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
Sponsor: Pyrotech Therapeutics, Inc.
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.
Official title: A Phase IIa, Multicenter, Single-Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Characteristics of PTT-621 in Patients With Moderately to Severely Active Ulcerative
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-08
Completion Date
2028-06
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
PTT-621 Tablets
PTT-621 Tablets
Locations (1)
Renji Hospital-Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China