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NOT YET RECRUITING
NCT07747155
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

PTT-621 Tablets

PTT-621 Tablets

Locations (1)

Renji Hospital-Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China