Clinical trial NCT03969888: A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
ABBV-3067
ABBV-2222, F508del Mutation
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of solid organ or hematopoietic transplant
* Cirrhosis with portal hypertension
* Use of CFTR modulator therapy within 60 days prior to Screening

Primary outcomes:
measure: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
timeFrame: Day 1 (Baseline) through Day 29
Secondary outcomes:
measure: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
timeFrame: Day 1 (Baseline) through Day 29
measure: Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
timeFrame: Day 1 (Baseline) through Day 29
measure: Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
timeFrame: Day 1 (Baseline) through Day 29
measure: Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
timeFrame: Day 1 (Baseline) through Day 29
measure: Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
timeFrame: Day 1 (Baseline) through Day 29
measure: Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
timeFrame: Day 1 (Baseline) through Day 29
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas /ID# 212541
state: Arkansas
city: Tampa
country: United States
facility: Tampa General Hospital /ID# 212342
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics /ID# 212351
state: Iowa
city: Ann Arbor
country: United States
facility: Univ Michigan Med Ctr /ID# 212657
state: Michigan
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital /ID# 212349
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 212352
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital /ID# 213158
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 212187
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 212353
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah /ID# 212350
state: Utah
city: Edegem
country: Belgium
facility: Uza /Id# 213412
state: Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413
state: Bruxelles-Capitale
city: Jette
country: Belgium
facility: UZ Brussel /ID# 212812
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 213411
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 213050
state: Vlaams-Brabant
city: Calgary
country: Canada
facility: University of Calgary /ID# 212555
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital /ID# 212554
state: British Columbia
city: Halifax
country: Canada
facility: QEII - Health Sciences Centre /ID# 212656
state: Nova Scotia
city: Toronto
country: Canada
facility: Unity Health Toronto - St. Michael's Hospital /ID# 212552
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center Research Institute /ID# 212553
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655
state: Quebec
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno /ID# 213437
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motole /ID# 212966
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 212862
state: Alpes-Maritimes
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 212899
state: Auvergne-Rhone-Alpes
city: Pessac
country: France
facility: CHU Bordeaux - Hopital Haut Leveque /ID# 212898
state: Gironde
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi /ID# 212856
state: Herault
city: Paris
country: France
facility: AP-HP - Hopital Cochin /ID# 212864
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche /ID# 212910
city: Roscoff
country: France
facility: Fondation ILDYS /ID# 212857
city: Saint-Herblain
country: France
facility: CHU Nantes - Hopital Laennec /ID# 212897
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 213494
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis /ID# 212926
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 212935
city: Epsom
country: New Zealand
facility: Greenlane Clinical Centre /ID# 221103
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital /ID# 221105
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 221102
state: Waikato
city: Otago
country: New Zealand
facility: Dunedin Hospital /ID# 221104
city: Gdansk
country: Poland
facility: Szpital Dzieciecy Polanki /ID# 221330
state: Pomorskie
city: Beograd
country: Serbia
facility: Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 213016
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust /ID# 212531
state: Nottinghamshire
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board /ID# 212504
state: Wales
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust /ID# 212507
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 212491
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291
city: London
country: United Kingdom
facility: Royal Brompton and Harefield Hospitals /ID# 212490
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: