A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Rescue Event During the DB Period
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).
详细描述
This is a randomized, double-blind, placebo-controlled study with an OLE.
Participants will be randomized to receive namilumab or placebo in the 26-week Double-blind Treatment Period of the study. Namilumab, or placebo, will be administered subcutaneously (SC) every 4 weeks through Week 22 after the initial dosing period.
All participants who complete the 26-week Double-blind Treatment Period, may be eligible to participate in the 28-week OLE.
Further details are in the protocol.
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)
盲法说明
Study drug will be provided in a blinded fashion and packaged and labeled to protect the blind.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment Arm 2
Placebo
干预措施: Placebo (Drug)
Treatment Arm 1
Namilumab
干预措施: Namilumab (Drug)
结局指标
主要结局
Percentage of Participants With a Rescue Event During the DB Period
时间窗: Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.
Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (oral corticosteroids \[OCS\] taper/immunosuppressive therapy \[IST\] removal/prohibited medication). Participants with premature treatment discontinuation in the DB period without rescue event were considered as with missing rescue event status and excluded from analysis.
次要结局
- Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26(Baseline, Week 26)
- Time to the First Rescue Event During the DB Period(Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.)
- Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period(Baseline to Week 26)
- Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26(Baseline, Week 26)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period(Baseline up to Week 26)