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Clinical Trial 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. 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 3 groups, called treatment arms. Each group receives a different treatment. Around 50 adult participants with a diagnosis of CF will be enrolled in the study around approximately 21 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. For both 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04853368
Study type Interventional
Source AbbVie
Phone 844-663-3742
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date June 29, 2021
Completion date January 7, 2022

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