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

Study Identifier
M19-771
CT.gov Identifier
NCT04853368
EudraCT Identifier
2020-005805-25
EUCTIS ID
Not available
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Protocol
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Statistical Analysis Plan
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Plain Language Summary
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Study Details

Medical Condition
  • Cystic Fibrosis
    • Study Drug
  • ABBV-576
  • Galicaftor
  • Placebo
  • Navocaftor
  • ABBV-119
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    \- Clinically significant laboratory values at screening that would pose undue risk for the participant or interfere with safety assessments (per the investigator).

    Protocol 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 death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor/navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm.

    Galicaftor/Navocaftor/ABBV-119 combination therapy and Galicaftor/Navocaftor/ABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide.

    Participants in arm 1 will receive oral capsules of galicaftor/navocaftor dual combination for 28 days followed by galicaftor/navocaftor/ABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor/navocaftor/ABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Velocity Clinical Research /ID# 248675
    Mobile, Alabama, United States, 36608-1771
    Status
    Not applicable
    Location
    University of Southern California /ID# 249147
    Los Angeles, California, United States, 90030
    Status
    Not applicable
    Location
    Ventura County Medical Center /ID# 248586
    Ventura, California, United States, 93003-1651
    Status
    Not applicable
    Location
    Central FL Pulmonary Orlando /ID# 245432
    Orlando, Florida, United States, 32803
    Status
    Not applicable
    Location
    University of Kansas Health Sy /ID# 249056
    Kansas City, Kansas, United States, 66160-8500
    Status
    Not applicable
    Location
    Boston Children's Hospital /ID# 248646
    Boston, Massachusetts, United States, 02115
    Status
    Not applicable
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