A 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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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 \[NR\]).

Key facts

Study ID

NCT02516410

Run by

Vertex Pharmaceuticals Incorporated

People needed

168

Starts

2015-08-01

Expected to finish

2016-06-07

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…

• Confirmed diagnosis of CF defined as a sweat chloride value greater than or equal to (>=)60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis.
• 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, genotype to be confirmed via assessment at the Screening Visit.
• Forced Expiratory Volume in 1 Second (FEV1) >=40 percent (%) and less than or equal to (<=)90% of predicted normal for age, sex, and height at Screening 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).
• History of solid organ or hematological transplantation.
• Ongoing or prior participation in an investigational drug study or use of commercially available CFTR modulator within 30 days of screening.
• Pregnant or nursing females.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Memphis, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Spokane, Washington, United States
• Study site — Brisban, Queensland, Australia
• Study site — Chermside, Australia
• Study site — Herston, Australia

Full record on ClinicalTrials.gov

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