Page Title
Clinical Trial Finder
Restore CFTR Protein Completed with Results
Phase 3 study of Vertex 661 and ivacaftor in people with CF who have one copy of the F508del-CFTR mutation and a second CFTR mutation with a gating defect responsive to ivacaftor (Vertex VX-661-109)
This study evaluated the safety and effectiveness of the drug VX-661 in combination with ivacaftor (Kalydeco®) in people already taking ivacaftor (Kalydeco®).
Participants, who were already taking ivacaftor, were randomized to receive either VX-661 (100mg once daily) in addition to ivacaftor (150mg twice daily) or placebo in addition to ivacaftor (150mg twice daily) for 8 weeks.
Eligibility
-
Age:
12 Years and Older -
Mutation(s):
One Copy F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
-
What We Learned:
This study found that adding VX-661 to ivacaftor did not have a significant impact on lung function (absolute change in percent predicted FEV1), sweat chloride, or a patient reported outcome questionnaire (CFQ-R) compared with ivacaftor alone. The addition of VX-661 to ivacaftor was generally well tolerated and consistent with prior phase 3 studies of the VX-661/ivacaftor combination.
-
Primary Findings:
Effectiveness:
This study was conducted between August 2015 and July 2017.
The study enrolled 144 participants (N=75 VX-661 plus ivacaftor, N=69 ivacaftor).
The primary objective of the study was change in lung function, measured by absolute change in percent predicted FEV1 from baseline through 8 weeks. This study did not meet its primary objective. Lung function improved by 0.5% in participants receiving VX-661 in addition to their ivacaftor compared with 0.2% in participants who received placebo in addition to their ivacaftor.
Sweat chloride decreased 7.9 mmol/L in participants who received VX-661 in addition to ivacaftor compared to placebo in addition to ivacaftor, but the change was not significant. There was no change in a patient reported outcome questionnaire (CFQ-R) compared to the placebo group.
Safety:
The addition of VX-661 to ivacaftor was generally well tolerated and consistent with other studies of the VX-661/ivacaftor combination.
These results have been provided from a Vertex Press Release and Clinicaltrials.gov and have not been peer reviewed.
-
Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
13 weeks -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Eligibility
-
Age:
12 Years and Older -
Mutation(s):
One Copy F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Sign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More