NCT07747155尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of participants achieving endoscopic improvement at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female participants aged 18-70 years inclusive at screening.
- •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-
- •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.
排除标准
- •1. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis/enteritis that could interfere with efficacy evaluation；
- •Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery)；
- •Prior or current gastrointestinal dysplasia；
- •History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.
研究组 & 干预措施
Participants receiving PTT-621 Dose A
Experimental
干预措施: PTT-621 Tablets (Drug)
结局指标
主要结局
Percentage of participants achieving endoscopic improvement at Week 12
时间窗: Week 12
次要结局
- 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)
- 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)
- Changes in high-sensitivity C-reactive protein (hsCRP) from baseline(Week 2, 4, 8, 12)
研究者
研究点 (1)
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