Status:
TERMINATED
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis
Lead Sponsor:
AbbVie
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of d...
Detailed Description
Participants in Cohorts 1 and 3 will receive Open-label therapy. Participants in Cohorts 2 will receive Double-blinded therapy.
Eligibility Criteria
Inclusion
- Confirmed clinical diagnosis of cystic fibrosis (CF).
- Arm 1 participants with genotype homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation and not receiving elexacaftor/tezacaftor/ivacaftor (ETI) treatment .
- Arm 2 and 3 participants with genotype heterozygous for the F508del CFTR mutation and a minimal function mutation and not receiving ETI treatment.
- Arm 4 participants with genotype either homozygous or heterozygous for the F508del mutation. Participants must be receiving stable ETI treatment.
- Percent predicted forced expiratory volume in 1 second (ppFEV1) \>= 40% and \<=90% of predicted normal for age, gender and height at screening.
- For arms 1 and 2: sweat chloride (SwCl) \>= 60 mmol/L at screening. For participants who participated in Study M19-530, it is acceptable to use a SwCl value that the central lab provided in Study M19-530 to establish eligibility.
- Weight \>= 35 kg at screening and Day -28 for arm 1 or day 1 for arms 2 to 4.
Exclusion
- \- Clinically significant laboratory values at screening that would pose undue risk for the participant or interfere with safety assessments (per the investigator).
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04853368
Start Date
September 20 2021
End Date
June 5 2023
Last Update
July 16 2024
Active Locations (41)
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1
Velocity Clinical Research /ID# 248675
Mobile, Alabama, United States, 36608-1771
2
University of Southern California /ID# 249147
Los Angeles, California, United States, 90030
3
Ventura County Medical Center /ID# 248586
Ventura, California, United States, 93003-1651
4
Central FL Pulmonary Orlando /ID# 245432
Orlando, Florida, United States, 32803