NCT05076175招募中2 期
A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 117
- 主要终点
- Proportion of participants who achieve clinical remission
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
- •Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
- •Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
排除标准
- •Diagnosis of Crohn's disease or indeterminate colitis
- •Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
- •Apheresis within 2 weeks of randomization
- •History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Ozanimod High Dose
Experimental
干预措施: Ozanimod (Drug)
Ozanimod Low Dose
Experimental
干预措施: Ozanimod (Drug)
结局指标
主要结局
Proportion of participants who achieve clinical remission
时间窗: At Week 52
次要结局
- Percent change from baseline in ALC(Up to 6 years)
- Proportion of participants who achieve symptomatic remission(At Week 10 and Week 52)
- Incidence of Serious Adverse Events(Up to 6 years)
- Incidence of AEs leading to discontinuation from treatment(Up to 6 years)
- Absolute change from baseline in Absolute Lymphocyte Count (ALC)(Up to 6 years)
- Proportion of participants who achieve clinical remission(At Week 10)
- Incidence of AEs of special interest (AESIs)(Up to 6 years)
- Time to achievement of symptomatic remission(Up to 6 years)
- Proportion of participants who achieve corticosteroid free remission(At Week 52)
- Steady state systemic exposure of ozanimod and CC112273(At Week 18 and throughout the study, up to 70 weeks)
- Proportion of participants who achieve clinical response(At Week 10)
- Proportion of participants who achieve endoscopic improvement(At Week 10 and Week 52)
- Incidence of Adverse Events (AEs)(Up to 6 years)
- Proportion of participants who achieve clinical response(At Week 52)
研究者
研究点 (117)
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