A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PTT-621 Tablets.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug PTT-621 Tablets
PTT-621 will be administered orally
Primary outcome measures
- Percentage of participants achieving endoscopic improvement at Week 12 [Time frame: Week 12]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital-Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07747155 · PTT-621-201