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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PTT-621 will be administered orally
Renji Hospital-Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Percentage of participants achieving endoscopic improvement at Week 12
Time frame: Week 12
Percentage of participants with adverse events (AEs)
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of participants achieving clinical remission、clinical response
Time frame: Week 12
Percentage of participants achieving symptom remission, symptom response
Time frame: Weeks 2, 4, 8, 12
Pharmacokinetic (PK) characteristics: Plasma concentrations of PTT-621
Time frame: Baseline, Weeks 2, 4, 8, 12
Changes in fecal calprotectin from baseline
Time frame: Weeks 2, 4, 8, 12
Changes in high-sensitivity C-reactive protein (hsCRP) from baseline
Time frame: Week 2, 4, 8, 12
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