A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 51
- 主要终点
- Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
研究概览
简要总结
This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.
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
- •Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
- •Stable pulmonary status
- •Lung function >= 40 and <= 90% of predicted normal for age, gender and height at Screening
排除标准
- •History of solid organ or hematopoietic transplant
- •Cirrhosis with portal hypertension
- •Use of CFTR modulator therapy within 60 days prior to Screening
研究组 & 干预措施
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
干预措施: Placebo ABBV-2222 (Drug)
ABBV-3067 150 mg + Placebo for ABBV-2222
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 150 mg + Placebo for ABBV-2222
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
干预措施: Placebo ABBV-2222 (Drug)
ABBV-3067 150 mg + ABBV-2222 10 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 150 mg + ABBV-2222 10 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
干预措施: ABBV-2222 (Drug)
ABBV-3067 150 mg + ABBV-2222 30 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 150 mg + ABBV-2222 30 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
干预措施: ABBV-2222 (Drug)
ABBV-3067 150 mg + ABBV-2222 100 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 150 mg + ABBV-2222 100 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
干预措施: ABBV-2222 (Drug)
ABBV-3067 150 mg + ABBV-2222 200 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 150 mg + ABBV-2222 200 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
干预措施: ABBV-2222 (Drug)
ABBV-3067 150 mg + ABBV-2222 300 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
干预措施: ABBV-3067 (Drug)
ABBV-3067 150 mg + ABBV-2222 300 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
干预措施: ABBV-2222 (Drug)
Placebo for ABBV-3067 + Placebo for ABBV-2222
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
干预措施: Placebo ABBV-3067 (Drug)
Placebo for ABBV-3067 + Placebo for ABBV-2222
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
干预措施: Placebo ABBV-2222 (Drug)
结局指标
主要结局
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
时间窗: Day 1 (Baseline) through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
次要结局
- Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)(Day 1 (Baseline) through Day 29)
- Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)(Day 1 (Baseline) through Day 29)
- Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)(Day 1 (Baseline) through Day 29)
- Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)(Day 1 (Baseline) through Day 29)
- Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)(Day 1 (Baseline) through Day 29)
- Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)(Day 1 (Baseline) through Day 29)