A study to evaluate a new triple combination therapy (CFTR modulators) in adults with CF
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Recruitment complete Participating Centres
- Trials Tracker ID
- TT007201
- Last updated
- 11/05/2022
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
Study detailsThe main aim of the study is to assess safety and effectiveness of the CFTR modulator combination therapy 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 an investigational therapy for the treatment of CF. Galicaftor (CFTR corrector), Navocaftor (CFTR potentiator) and ABBV-119 (CFTR corrector) are CFTR modulators which aim to help the faulty CFTR protein to function properly. Study doctors place participants into 1 of 4 treatment groups, called treatment arms. Each group receives a different treatment regime. Around 90 adult participants with a diagnosis of CF will be enrolled in the study from around approximately 35 sites worldwide.
- Phase
- Phase 2
- Length of participation
- Up to 4 months
- Recruitment target
- 20
- CF sponsor
- AbbVie
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
Age: 18 years and older
Arm 1 participants: genotype homozygous for F508del and not receiving Kaftrio® treatment.
Arm 2 and 3 participants: genotype heterozygous for F508del and a minimal function mutation and not receiving Kaftrio® treatment.
Arm 4 participants: genotype either homozygous or heterozygous for the F508del mutation. Participants must be receiving stable Kaftrio® treatment.
FEV1 between 40% and 90% of predicted normal for age, gender and height at screening.