A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Key facts

Study ID

NCT02508207

Run by

Vertex Pharmaceuticals Incorporated

People needed

34

Starts

2016-02-01

Expected to finish

2017-06-01

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants, homozygous for the F508del CFTR mutation
• Confirmed diagnosis of CF by sweat chloride testing
• Forced Expiratory Volume in 1 Second (FEV1) ≥40% and ≤90% of predicted normal for age, sex, and height at Screening Visit
• Stable CF disease as judged by the investigator.

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 subject.
• An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1
• History or evidence of clinically significant findings on ophthalmologic examination during the Screening Period.
• History of solid organ or hematological transplantation
• Pregnant or nursing females
• Participants who have had radiation exposure within 1 year before the first mucociliary clearance (MCC) procedure that would cause them to exceed federal regulations by participating in this study
• In the opinion of the investigator, unable to adequately perform inhalation maneuvers during the MCC procedures

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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