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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02347657

Run by

Vertex Pharmaceuticals Incorporated

People needed

510

Starts

2015-01-01

Expected to finish

2017-01-20

Last updated by the study team

2018-06-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Long Beach, California, United States
• Study site — Denver, Colorado, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Manchester, New Hampshire, United States
• Study site — Long Branch, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albany, New York, United States
• Study site — Buffalo, New York, United States
• Study site — New Hyde Park, New York, United States
• Study site — Rochester, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Charleston, South Carolina, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Fort Worth, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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