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

Bristol-Myers Squibb124 个研究点分布在 1 个国家目标入组 120 人2022年5月30日

适应症Colitis, Ulcerative

干预措施Ozanimod

概览

阶段: 2 期
干预措施: Ozanimod
疾病 / 适应症: Colitis, Ulcerative
发起方: Bristol-Myers Squibb
入组人数: 120
试验地点: 124
主要终点: Proportion of participants who achieve clinical remission
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2022年5月30日

结束日期

2031年8月14日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Bristol-Myers Squibb

责任方

Sponsor

入排标准

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 Low Dose

干预措施: Ozanimod

Ozanimod High Dose

干预措施: Ozanimod

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)