A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 68
- 试验地点
- 36
- 主要终点
- Change From Baseline in Forced Vital Capacity (FVC) at Week 26
研究概览
简要总结
This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).
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
- 40 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
GLPG1205 100 mg
Participants will receive GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
干预措施: GLPG1205 (Drug)
Placebo
Participants will receive GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Forced Vital Capacity (FVC) at Week 26
时间窗: Baseline, Week 26
Forced vital capacity (FVC) (in milliliter \[mL\]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation(First dose date up to 30 days after the last dose of study drug (maximum up to 263 days))
- Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations(Day 1 up to Week 30)
- Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26(Baseline, Week 26)
- Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26(Baseline, Week 26)
- Change From Baseline in SGRQ Domain Score at Week 26(Baseline, Week 26)
- Percentage of SGRQ Responders(Baseline up to Week 26)
- Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26(Week 26 (pre-dose))
- Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20(Week 20 (pre-dose))
- Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20(Week 20 (pre-dose))