A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: ABBV-3067Drug: Placebo ABBV-3067Drug: Placebo ABBV-2222Drug: ABBV-2222
- 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 + 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 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 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.
Trial Locations
- Locations (51)
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596
🇸🇰Bratislava, Slovakia
AP-HP - Hopital Cochin /ID# 212864
🇫🇷Paris, France
Medical University of South Carolina /ID# 212187
🇺🇸Charleston, South Carolina, United States
University of Iowa Hospitals and Clinics /ID# 212351
🇺🇸Iowa City, Iowa, United States
University of Arkansas /ID# 212541
🇺🇸Little Rock, Arkansas, United States
Tampa General Hospital /ID# 212342
🇺🇸Tampa, Florida, United States
Vanderbilt University Medical Center /ID# 212353
🇺🇸Nashville, Tennessee, United States
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815
🇨🇦Montreal, Quebec, Canada
Chu de Nice-Hopital L'Archet Ii /Id# 212862
🇫🇷Nice, Alpes-Maritimes, France
Fakultni Nemocnice v Motole /ID# 212966
🇨🇿Praha, Czechia
Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655
🇨🇦Québec, Quebec, Canada
CHU Bordeaux - Hopital Haut Leveque /ID# 212898
🇫🇷Pessac, Gironde, France
Barts Health NHS Trust /ID# 213016
🇬🇧London, London, City Of, United Kingdom
Cardinal Glennon Children's Hospital /ID# 212349
🇺🇸Saint Louis, Missouri, United States
Nationwide Children's Hospital /ID# 213158
🇺🇸Columbus, Ohio, United States
Washington University-School of Medicine /ID# 212352
🇺🇸Saint Louis, Missouri, United States
Uza /Id# 213412
🇧🇪Edegem, Antwerpen, Belgium
Unity Health Toronto - St. Michael's Hospital /ID# 212552
🇨🇦Toronto, Ontario, Canada
QEII - Health Sciences Centre /ID# 212656
🇨🇦Halifax, Nova Scotia, Canada
McGill University Health Center Research Institute /ID# 212553
🇨🇦Montreal, Quebec, Canada
Fakultni Nemocnice Brno /ID# 213437
🇨🇿Brno, Czechia
HCL - Hopital Lyon Sud /ID# 212899
🇫🇷Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
CHU Nantes - Hopital Laennec /ID# 212897
🇫🇷Saint-Herblain, France
CHU de Reims - Hôpital Maison Blanche /ID# 212910
🇫🇷Reims, France
Fondation ILDYS /ID# 212857
🇫🇷Roscoff, France
Orszagos Koranyi Pulmonologiai Intezet /ID# 213494
ðŸ‡ðŸ‡ºBudapest, Hungary
HagaZiekenhuis /ID# 212926
🇳🇱Den Haag, Netherlands
Universitair Medisch Centrum Utrecht /ID# 212935
🇳🇱Utrecht, Netherlands
Waikato Hospital /ID# 221102
🇳🇿Hamilton, Waikato, New Zealand
Greenlane Clinical Centre /ID# 221103
🇳🇿Epsom, Auckland, New Zealand
Christchurch Hospital /ID# 221105
🇳🇿Christchurch, Canterbury, New Zealand
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146
🇸🇰Bratislava, Slovakia
Dunedin Hospital /ID# 221104
🇳🇿Otago, New Zealand
Szpital Dzieciecy Polanki /ID# 221330
🇵🇱Gdansk, Pomorskie, Poland
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820
🇷🇸Beograd, Serbia
Cardiff & Vale University Health Board /ID# 212504
🇬🇧Cardiff, Wales, United Kingdom
Royal Brompton and Harefield Hospitals /ID# 212490
🇬🇧London, United Kingdom
Nottingham University Hospitals NHS Trust /ID# 212531
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 212491
🇬🇧Leeds, United Kingdom
Royal Papworth Hospital NHS Foundation Trust /ID# 212507
🇬🇧Cambridge, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291
🇬🇧Liverpool, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665
🇬🇧Newcastle upon Tyne, United Kingdom
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413
🇧🇪Brussels, Bruxelles-Capitale, Belgium
UZ Brussel /ID# 212812
🇧🇪Jette, Bruxelles-Capitale, Belgium
UZ Gent /ID# 213411
🇧🇪Gent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 213050
🇧🇪Leuven, Vlaams-Brabant, Belgium
CHU Montpellier - Hôpital Saint Eloi /ID# 212856
🇫🇷Montpellier Cedex 5, Herault, France
Univ Michigan Med Ctr /ID# 212657
🇺🇸Ann Arbor, Michigan, United States
University of Utah /ID# 212350
🇺🇸Salt Lake City, Utah, United States
University of Calgary /ID# 212555
🇨🇦Calgary, Alberta, Canada
St. Paul's Hospital /ID# 212554
🇨🇦Vancouver, British Columbia, Canada