A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
研究概览
简要总结
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
- •Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
- •If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
- •Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
- •Additional criteria exist.
排除标准
- •Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
- •Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
- •Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
- •Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
- •Specific abnormal laboratory values or electrocardiogram abnormalities.
- •Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.
- •Additional criteria exist.
研究组 & 干预措施
Placebo
干预措施: Placebo; oral (Drug)
ARRY-371797 (Schedule 1)
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
ARRY-371797 (Schedule 2)
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
ARRY-371797 (Schedule 2)
干预措施: Placebo; oral (Drug)
结局指标
主要结局
Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
时间窗: 12 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: 12 weeks
次要结局
- Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.(12 weeks)
- Explore potential biomarkers for pharmacodynamics (PD).(12 weeks)