NCT05287126招募中2 期
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 90
- 主要终点
- Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
研究概览
简要总结
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
- •Participants are permitted to be receiving a therapeutic dose of select UC therapies
排除标准
- •Severe extensive colitis
- •Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- •Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
研究组 & 干预措施
Etrasimod
Experimental
干预措施: Etrasimod (Drug)
结局指标
主要结局
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
时间窗: Week 52
次要结局
- Proportion of Participants Achieving Clinical Response at Week 12(Week 12)
- Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)(4 hours (± 15 minutes) post-dose)
- Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12(Week 12)
- Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52(Week 52)
- Proportion of Participants Achieving Endoscopic Improvement at Week 12(Week 12)
- Proportion of Participants Achieving Symptomatic Remission at Week 52(Week 52)
- Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12(Week 12)
- Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod(pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52(Week 52)
- Proportion of Participants Achieving Clinical Response at Week 52(Week 52)
- Number and Severity of Adverse Events(Up to Week 52)
- Proportion of Participants Achieving Endoscopic Improvement at Week 52(Week 52)
- Proportion of Participants Achieving Symptomatic Remission at Week 12(Week 12)
- Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12(Week 12)
- Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52(Week 52)
- Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12(Week 12)
研究者
研究点 (90)
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