A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of Duvelisib With Background Methotrexate in Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 主要终点
- Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), IPI-145, in combination with methotrexate compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.
详细描述
This Phase 2 study is designed to examine the efficacy and safety of multiple dose levels of IPI-145 in subjects with active moderate-to-severe Rheumatoid Arthritis receiving a background stable dose of methotrexate. The study will employ a randomized, double-blind, placebo-controlled, parallel design.
Approximately 316 adult subjects who meet all eligibility criteria at Screening will be randomized at Baseline in a 1:1:1:1 ratio to one of 4 dose groups.
All treatments will be administered twice a day (BID). After randomization, subjects will enter a 12-week Treatment Period, where study drug (IPI-145 or placebo) will be self-administered BID as an outpatient. During the Treatment Period, subjects will return to the clinic for efficacy and safety assessments every 2 weeks. Following Treatment Period completion at Week 12, subjects will enter a 3-week Follow-up Period which includes one clinic visit approximately 3 weeks after the last dose of study drug.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Rheumatoid Arthritis for at least 6 months
- •Active disease, based on Screening clinical and laboratory criteria, despite taking methotrexate for at least 3 months
排除标准
- •Pregnant or lactating females
- •Previous failure or inadequate response to >2 biologic disease-modifying anti-rheumatic drugs (DMARDs)
- •Concurrent DMARD treatment other than methotrexate, sulfasalazine, chloroquine, or hydroxychloroquine
- •Treatment with > 10 mg daily prednisone (or equivalent) or more than one non-steroidal anti-inflammatory drug
研究组 & 干预措施
IPI-145, low dose BID
干预措施: IPI-145 (Drug)
IPI-145, medium dose BID
干预措施: IPI-145 (Drug)
IPI-145, high dose BID
干预措施: IPI-145 (Drug)
Placebo BID
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
时间窗: Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12
次要结局
未报告次要终点