At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 77 enrolled
Drug / intervention
VX-561 +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 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating VX-561, IVA, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 77 participants across 48 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Germany, Ireland, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartApr 2019
Primary CompletionAug 2020
TodayJul 2026
First PostedApr 11, 2019
Enrollment StartApr 17, 2019
Primary CompletionAug 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.2 years ago
Interventions
VX-561drug
VX-561 tablets for oral administration.
IVAdrug
150-mg film-coated tablet for oral administration.
Placebodrug
Placebo matched to IVA.
Placebodrug
Placebos matched to VX-561.