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
NCT ID: NCT02516410
Last Updated: 2018-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2015-08-31
2016-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VX-661/IVA
VX-661 100 milligram (mg) plus IVA 150 mg fixed dose combination (FDC) tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
VX-661 plus ivacaftor combination
Ivacaftor
Placebo
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
Placebo (matched to VX-661 plus ivacaftor combination)
Placebo (matched to ivacaftor)
Interventions
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VX-661 plus ivacaftor combination
Ivacaftor
Placebo (matched to VX-661 plus ivacaftor combination)
Placebo (matched to ivacaftor)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
La Jolla, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Cincinnati, Ohio, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Brisban, Queensland, Australia
Chermside, , Australia
Herston, , Australia
Innsbruck, , Australia
Westmead, , Australia
Graz, , Austria
Innsbruck, , Austria
Salzburg, , Austria
Vancouver, British Columbia, Canada
Montreal, , Canada
Bron, , France
Montpellier, , France
Paris, , France
Haifa, , Israel
Hashomer, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Barcelona, , Spain
Valencia, , Spain
Countries
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References
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Munck A, Kerem E, Ellemunter H, Campbell D, Wang LT, Ahluwalia N, Owen CA, Wainwright C. Tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for minimal function CFTR mutations. J Cyst Fibros. 2020 Nov;19(6):962-968. doi: 10.1016/j.jcf.2020.04.015. Epub 2020 Jun 13.
Other Identifiers
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2014-004787-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX14-661-107
Identifier Type: -
Identifier Source: org_study_id
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