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Restore CFTR Protein Completed with Results
Study of VX-661 plus ivacaftor in people with CF who have two copies of the F508del CFTR mutation (Vertex VX-661-111)
This study evaluated the safety and effectiveness of the CFTR modulator drug VX-661 in combination with ivacaftor (Symdeko®). This study was for people with CF who have two copies of the F508del CFTR mutation.
This study was placebo-controlled, meaning that some participants received the study drug, and others received a placebo. Participants were randomly assigned to receive either VX-661 (100mg once a day) in combination with ivacaftor (150mg twice a day) or placebo for 29 days.
Eligibility
See other primary eligibility criteria for more information.
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Age:
18 Years and Older -
Mutation(s):
Two Copies F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Only patients that are homozygous for the F508del CFTR mutation will be included.
Study Results
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What We Learned:
This study found that VX-661 plus ivacaftor, when compared with placebo, did not have a significant impact on Mucociliary Clearance (MCC), an imaging technique that tracks mucus within the lung. However, participants receiving VX-661 plus ivacaftor did experience a significant improvement in lung function when compared with placebo. VX-661 plus ivacaftor was well-tolerated.
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Primary Findings:
Effectiveness:
This study was conducted between February 2016 and June 2017. This study enrolled 34 participants (VX-661 plus ivacaftor N=27, placebo N=7).
The primary objective of this study was the change in Mucociliary Clearance (MCC) from the start of the study to Day 28. MCC is an imaging technique that tracks mucus within the lung. This study did not meet its primary endpoint as the MCC difference between VX-661 plus ivacaftor and placebo was not significant.
Notably, participants receiving VX-661 plus ivacaftor did experience a significant improvement in lung function (as measured by absolute change in FEV1) when compared with placebo (2.4 and -.4 respectively, p=0.0004).
Safety:
VX-661 plus ivacaftor was well-tolerated.
These results have been provided by Clinicaltrials.gov and have not been peer-reviewed.
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Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
60 days -
Number of Study Visits:
6
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
Two Copies F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Only patients that are homozygous for the F508del CFTR mutation will be included.
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