Ulcerative Colitis (UC)
Conditions
Keywords
Ulcerative Colitis, IBD
Brief 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.
Interventions
DRUGPTT-621 Tablets
PTT-621 will be administered orally
Sponsors
Pyrotech Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female participants aged 18-70 years inclusive at screening. 2. Diagnosed with ulcerative colitis (UC) at least 60 days prior to the first dose of IP. 3\. Participants have active UC at screening, defined as a modified Mayo score of 5-9. 4\. Endoscopic evidence of UC extending ≥15 cm from the anal verge during the screening period. 5\. Participants have had inadequate/loss of response or intolerance to at least one of the following: 5-aminosalicylic acid, glucocorticoids, immunosuppressants, biologics, and/or small-molecule targeted therapies. 6\. Participants currently receiving the following UC therapies are eligible if they meet stability requirements: Oral glucocorticoids: with stable dosing for ≥2 weeks prior to screening endoscopy；Oral 5-ASA: Stable dose for at least 2 weeks prior to the endoscopic assessment during the screening period. 7\. Female participants of childbearing potential must have a negative serum/urine pregnancy test at screening. 8\. Willing to use at least one highly effective contraceptive method during sexual intercourse throughout the study and until 1 month after the last dose of IP. 9\. Willing to refrain from sperm/ova donation throughout the study and until 1 month after the last dose of IP. 10\. Able and willing to provide written informed consent and comply with all protocol-specified procedures and visit schedules.
Exclusion criteria
* 1\. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis/enteritis that could interfere with efficacy evaluation； 2. Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery)； 3. Prior or current gastrointestinal dysplasia； 4. History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving endoscopic improvement at Week 12 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with adverse events (AEs) | Baseline, Week 2, 4, 8, 12 |
| Percentage of participants achieving clinical remission、clinical response | Week 12 |
| Percentage of participants achieving symptom remission, symptom response | Weeks 2, 4, 8, 12 |
| Pharmacokinetic (PK) characteristics: Plasma concentrations of PTT-621 | Baseline, Weeks 2, 4, 8, 12 |
| Changes in fecal calprotectin from baseline | Weeks 2, 4, 8, 12 |
| Changes in high-sensitivity C-reactive protein (hsCRP) from baseline | Week 2, 4, 8, 12 |
Countries
China
Contacts
CONTACTRan Wei
Outcome results
None listed