A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).
详细描述
The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID.
Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
- •Moderate to severe active UC.
- •Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab).
排除标准
- •Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
- •History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
- •History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening.
- •Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
- •Positive stool test for C. difficile.
- •Chronic recurrent or serious infection.
- •Known primary or secondary immunodeficiency.
- •Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
- •History of any major neurological disorders.
研究组 & 干预措施
PN-943 150 mg BID
Oral administration of PN-943 150 mg BID
干预措施: PN-943 (Drug)
PN-943 450 mg BID
Oral administration of PN-943 450 mg BID
干预措施: PN-943 (Drug)
Placebo BID
Oral administration of matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
时间窗: Week 12
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS)
次要结局
- Comparison between PN-943 high-dose and low-dose individually to placebo.(Week 12)