* A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.
Research type
Research Study
Full title
A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation.
IRAS ID
1004477
Contact name
Alice Butler
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2020-005805-25
ISRCTN Number
ISRCTN48897533
Clinicaltrials.gov Identifier
Research 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.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0214
Date of REC Opinion
3 Mar 2022
REC opinion
Further Information Favourable Opinion