A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969888
• Other study ID #: M19-530
• Secondary ID: 2019-000750-63
• Status: Completed
• Phase: Phase 2
• Start date: December 11, 2019
• Est. completion date: June 9, 2022

Study information

• Verified date: June 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• ABBV-3067
Tablet taken orally.
• Placebo ABBV-3067
Tablet taken orally.
• ABBV-2222
Capsule taken orally.
• Placebo ABBV-2222
Capsule taken orally.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Hungary,  Netherlands,  New Zealand,  Poland,  Serbia,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)	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.	Day 1 (Baseline) through Day 29
Secondary	Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)	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.	Day 1 (Baseline) through Day 29
Secondary	Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)	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.	Day 1 (Baseline) through Day 29
Secondary	Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)	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.	Day 1 (Baseline) through Day 29
Secondary	Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)	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.	Day 1 (Baseline) through Day 29
Secondary	Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)	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.	Day 1 (Baseline) through Day 29
Secondary	Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)	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.	Day 1 (Baseline) through Day 29