Overview

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

Status:
Completed
Trial end date:
2017-01-20
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Treatments:
Ivacaftor
Criteria
Inclusion Criteria:

- Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening
Visit

- Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative
pilocarpine iontophoresis

- Forced expiratory volume at one second (FEV1) ≥40% and ≤90% of predicted normal for
age, sex, and height during screening

- Stable CF disease as judged by the investigator

- Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
the Safety Follow up Visit

Exclusion Criteria:

- History of any comorbidity that, in the opinion of the investigator, might confound
the results of the study or pose an additional risk in administering study drug to the
participant.

- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
(first dose of study drug)

- Pregnant or nursing females (females of childbearing potential must have a negative
pregnancy test at Screening and Day 1)

- Sexually active participants of reproductive potential who are not willing to follow
the contraception requirements