Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Adult Participants With Cystic Fibrosis

  • STATUS
    Recruiting
  • End date
    Oct 14, 2022
  • participants needed
    90
  • sponsor
    AbbVie
Updated on 21 November 2021
fibrosis
forced expiratory volume
ivacaftor
tezacaftor
elexacaftor

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 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm.

Galicaftor/Navocaftor/ABBV-119 combination therapy 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-119 triple combination therapy for 28 days. For all study arms, 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.

Details
Condition Lung Disease, Cystic Fibrosis, Pancreatic Disorders, Pulmonary Disease, Pancreatic disorder
Treatment Placebo, Galicaftor, Navocaftor, ABBV-119
Clinical Study IdentifierNCT04853368
SponsorAbbVie
Last Modified on21 November 2021

Eligibility

Yes No Not Sure

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 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 1,2 and 3: 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)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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