A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 16
- 主要终点
- Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
研究概览
简要总结
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).
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
- •Signed informed consent prior to any study-mandated procedure.
- •Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
- •Women of childbearing potential must agree to use a reliable method of birth control.
排除标准
- •Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
- •Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
- •Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
- •Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
- •Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
- •Severe renal insufficiency (at randomization).
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
研究组 & 干预措施
Placebo
Placebo matching selexipag tablets is administered according to the same schedule as selexipag
干预措施: Placebo (Drug)
Selexipag
Selexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD.
干预措施: Selexipag (Drug)
结局指标
主要结局
Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
时间窗: From Day 26 to Day 56 ( +/- 7 days)
The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).
次要结局
- Number of patients with treatment-emergent adverse events(Up to end of study (Day 86 +/- 7 days))
- Number of patients with treatment-emergent serious adverse events(Up to end of study (Day 86 +/- 7 days))