A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
- Conditions
- Cystic Fibrosis
- Interventions
- Registration Number
- NCT03969888
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- History of solid organ or hematopoietic transplant
- Cirrhosis with portal hypertension
- Use of CFTR modulator therapy within 60 days prior to Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-3067 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-3067 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days. ABBV-3067 150 mg + Placebo for ABBV-2222 Placebo ABBV-2222 Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 100 mg ABBV-2222 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-2222 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days. ABBV-3067 50 mg + Placebo for ABBV-2222 ABBV-3067 Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days. ABBV-3067 50 mg + Placebo for ABBV-2222 Placebo ABBV-2222 Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 10 mg ABBV-2222 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-3067 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days. ABBV-3067 150 mg + Placebo for ABBV-2222 ABBV-3067 Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 30 mg ABBV-2222 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days. Placebo for ABBV-3067 + Placebo for ABBV-2222 Placebo ABBV-3067 Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 200 mg ABBV-3067 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 300 mg ABBV-3067 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days. ABBV-3067 150 mg + ABBV-2222 300 mg ABBV-2222 Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days. Placebo for ABBV-3067 + Placebo for ABBV-2222 Placebo ABBV-2222 Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) 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.
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) Day 1 (Baseline) through Day 29 Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) Day 1 (Baseline) through Day 29 FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) Day 1 (Baseline) through Day 29 FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) 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. MMRM was used for analyses.
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) Day 1 (Baseline) through Day 29 FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) Day 1 (Baseline) through Day 29 FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (51)
University of Arkansas /ID# 212541
🇺🇸Little Rock, Arkansas, United States
Tampa General Hospital /ID# 212342
🇺🇸Tampa, Florida, United States
University of Iowa Hospitals and Clinics /ID# 212351
🇺🇸Iowa City, Iowa, United States
Univ Michigan Med Ctr /ID# 212657
🇺🇸Ann Arbor, Michigan, United States
Cardinal Glennon Children's Hospital /ID# 212349
🇺🇸Saint Louis, Missouri, United States
Washington University-School of Medicine /ID# 212352
🇺🇸Saint Louis, Missouri, United States
Nationwide Children's Hospital /ID# 213158
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina /ID# 212187
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center /ID# 212353
🇺🇸Nashville, Tennessee, United States
University of Utah /ID# 212350
🇺🇸Salt Lake City, Utah, United States
Scroll for more (41 remaining)University of Arkansas /ID# 212541🇺🇸Little Rock, Arkansas, United States