A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
NCT ID: NCT03911713
Last Updated: 2022-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2019-04-17
2020-08-20
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
QUADRUPLE
Study Groups
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Ivacaftor
Participants received IVA 150 milligrams (mg) orally every 12 hours (q12h) in the treatment period for 12 weeks.
IVA
150-mg film-coated tablet for oral administration.
Placebo
Placebos matched to VX-561.
VX-561: 25 mg
Participants received VX-561 25 mg orally daily (qd) in the treatment period for 12 weeks.
VX-561
VX-561 tablets for oral administration.
Placebo
Placebo matched to IVA.
VX-561: 50 mg
Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
VX-561
VX-561 tablets for oral administration.
Placebo
Placebo matched to IVA.
VX-561: 150 mg
Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
VX-561
VX-561 tablets for oral administration.
Placebo
Placebo matched to IVA.
VX-561: 250 mg
Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
VX-561
VX-561 tablets for oral administration.
Placebo
Placebo matched to IVA.
Interventions
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VX-561
VX-561 tablets for oral administration.
IVA
150-mg film-coated tablet for oral administration.
Placebo
Placebo matched to IVA.
Placebo
Placebos matched to VX-561.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On ivacaftor therapy
* FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height
Exclusion Criteria
* History of solid organ or hematological transplantation
* Lung infection with organisms associated with a more rapid decline in pulmonary status
18 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Miller Children's Hospital / Long Beach Memorial
Long Beach, California, United States
UCSF Gateway Medical Center
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine / St. Louis Children's Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
UC Health Holmes
Cincinnati, Ohio, United States
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Dell Children's Medical Group
Austin, Texas, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah / Primary Children's Medical Center
Salt Lake City, Utah, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
The Prince Charles Hospital
Chermside, , Australia
Alfred Hospital
Melbourne, VIC, , Australia
Mater Adult Hospital
South Brisbane, , Australia
Westmead Hospital
Westmead, , Australia
Universitair Ziekenhuis Gent
Ghent, , Belgium
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
Erlangen, , Germany
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
Essen, , Germany
Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie
Halle, , Germany
Pneumologisches Studienzentrum Muenchen-West
München, , Germany
University Hospital Wuerzburg
Würzburg, , Germany
Beaumont Hospital
Dublin, , Ireland
Cork University Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
University Hospital Limerick (Adults)
Limerick, , Ireland
UMC St. Radboud
Nijmegen, , Netherlands
Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow, , United Kingdom
St. James University Hospital
Leeds, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Countries
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References
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Uluer AZ, MacGregor G, Azevedo P, Indihar V, Keating C, Mall MA, McKone EF, Ramsey BW, Rowe SM, Rubenstein RC, Taylor-Cousar JL, Tullis E, Yonker LM, Chu C, Lam AP, Nair N, Sosnay PR, Tian S, Van Goor F, Viswanathan L, Waltz D, Wang LT, Xi Y, Billings J, Horsley A; VX18-121-101; VX18-561-101 Study Groups. Safety and efficacy of vanzacaftor-tezacaftor-deutivacaftor in adults with cystic fibrosis: randomised, double-blind, controlled, phase 2 trials. Lancet Respir Med. 2023 Jun;11(6):550-562. doi: 10.1016/S2213-2600(22)00504-5. Epub 2023 Feb 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003970-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX18-561-101
Identifier Type: -
Identifier Source: org_study_id
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