A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 17
- 主要终点
- Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
研究概览
简要总结
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
详细描述
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .
- •Must be on a stable MTX dose (7.5 to 25 mg/week)
- •Subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
- •Are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
排除标准
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
- •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
- •Subjects who have taken any investigational drug within the previous 30 days before randomization.
- •Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
- •Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
- •Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
研究组 & 干预措施
ACP-196 + Methotrexate
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
干预措施: acalabrutinib (Drug)
Placebo + Methotrexate
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
干预措施: Placebo (Drug)
结局指标
主要结局
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
时间窗: 4 weeks
Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.
次要结局
未报告次要终点