A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis

Официальное название

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

Обзор

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.

Вмешательства

• Препарат PTT-621 Tablets
  PTT-621 will be administered orally

Первичные конечные точки

• Percentage of participants achieving endoscopic improvement at Week 12 [Срок оценки: Week 12]

Вторичные конечные точки (6)

• Percentage of participants with adverse events (AEs) [Срок оценки: Baseline, Week 2, 4, 8, 12]
• Percentage of participants achieving clinical remission、clinical response [Срок оценки: Week 12]
• Percentage of participants achieving symptom remission, symptom response [Срок оценки: Weeks 2, 4, 8, 12]
• Pharmacokinetic (PK) characteristics: Plasma concentrations of PTT-621 [Срок оценки: Baseline, Weeks 2, 4, 8, 12]
• Changes in fecal calprotectin from baseline [Срок оценки: Weeks 2, 4, 8, 12]
• Changes in high-sensitivity C-reactive protein (hsCRP) from baseline [Срок оценки: Week 2, 4, 8, 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renji Hospital-Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07747155 · PTT-621-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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