A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
研究概览
简要总结
The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment.
There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.
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
- Double (Participant, Investigator)
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
- •Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report criteria
- •Must have a body weight of > 40 kg (88.2 lb) at study screening
- •Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at screening
- •Two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 criteria:
- •The relative difference of FEV1(L), calculated as the absolute value of [(first FEV1 - second FEV1) / first FEV1] x 100 should be < 12% AND
- •The absolute difference in FEV1 should be < 200 ml
- •Negative Sputum Investigation/History of any Mycobacterium spp. or Burkholderia spp. per specified protocol-defined time periods
- •Clinically stable with no evidence of significant respiratory symptoms that would require administration of IV antibiotics, oxygen supplementation, or hospitalization within 30 days of baseline.
- •On stable CF chronic medical regimen for at least 30 days prior to baseline and expected to remain stable through the completion of the study. This includes but is not limited to: chronic azithromycin use, inhaled bronchodilators, inhaled corticosteroids, inhaled dornase alpha, inhaled hypertonic saline, inhaled mannitol, ivacaftor, and/or ivacaftor/lumacaftor.
排除标准
- •Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics within 30 days of baseline. Prophylactic and chronic doxycycline use is prohibited during the study.
- •Hospitalization for a respiratory event within 30 days of baseline
- •Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline
- •Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this exclusion criterion if supplemental oxygen is used for comfort only)
- •History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Andecaliximab 600 mg (Part 1)
Andecaliximab 600 mg weekly for 8 weeks
干预措施: Andecaliximab (Drug)
Placebo (Part 1)
Placebo weekly for 8 weeks
干预措施: Placebo (Drug)
Andecaliximab 300 mg (Part 2)
Andecaliximab 300 mg weekly for 8 weeks
干预措施: Andecaliximab (Drug)
Andecaliximab 150 mg (Part 2)
Andecaliximab 150 mg + placebo weekly for 8 weeks
干预措施: Andecaliximab (Drug)
Andecaliximab 150 mg (Part 2)
Andecaliximab 150 mg + placebo weekly for 8 weeks
干预措施: Placebo (Drug)
Placebo (Part 2)
Placebo weekly for 8 weeks
干预措施: Placebo (Drug)
Open-Label Extension
(Part 1) Andecaliximab 600 mg weekly for 16 weeks; (Part 2) Andecaliximab 300 mg weekly for 16 weeks
干预措施: Andecaliximab (Drug)
结局指标
主要结局
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
时间窗: Baseline; Week 8
次要结局
- Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8(Baseline; Week 8)
- Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8(Baseline; Week 8)
- Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8(Baseline; Week 8)