At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 168 enrolled
Drug / intervention
VX-661 plus ivacaftor combination +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)
In Brief
A Phase 3 clinical trial evaluating VX-661 plus ivacaftor combination, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 168 participants across 41 sites in 7 countries.
Detailed Summary
Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Austria, Canada, France, Israel, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedAug 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedAug 5, 2015
Enrollment StartAug 1, 2015
Primary CompletionJun 7, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.9 years ago
Interventions
VX-661 plus ivacaftor combinationdrug
Ivacaftordrug
Placebo (matched to VX-661 plus ivacaftor combination)drug
Placebo (matched to ivacaftor)drug