Page Title
Clinical Trial Finder
Restore CFTR Protein Completed with Results
Study of galicaftor/navocaftor/ABBV-576 combination therapy in adults with cystic fibrosis who have at least one F508del mutation and are on stable elexacaftor/tezacaftor/ivacaftor (Trikafta) treatment. (Abbvie M19-771)
This study looked at the safety and effectiveness of galicaftor/navocaftor/ABBV-576 combination therapy, a combination of CFTR modulators intended to improve CFTR function. This study enrolled adults with cystic fibrosis who had at least one F508del mutation.
Participants in Cohort 3 received the galicaftor/navocaftor/ABBV-576 triple-combination therapy once daily for 28 days. All study participants received the study drug; no placebo was used in Cohort 3 of this trial.Researchers tested the effectiveness of the study medication by measuring sweat chloride and lung function.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
Two Copies F508del or 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.
Other Primary Eligibility Criteria
Participants must be willing to stop taking Trikafta before starting on Abbvie's triple combination modulator for 28 days and then the participants can resume ETI treatment after the study treatment period.
Study Results
-
What We Learned:
The study enrolled eleven participants and was terminated early due to no observed benefit of the triple combination.
-
Primary Findings:
Effectiveness:
This study was conducted between January 2023 and June 2023. The study enrolled 11 participants and was terminated early due to no observed benefit of the triple combination.
Safety:
-
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
No -
Placebo Controlled: ?more info
No -
Length of Participation:
3 months -
Number of Study Visits:
6
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
AbbVie -
Study Drugs:
N/A
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
Two Copies F508del or 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.
Other Primary Eligibility Criteria
Participants must be willing to stop taking Trikafta before starting on Abbvie's triple combination modulator for 28 days and then the participants can resume ETI treatment after the study treatment period.
CONTACT THE CLINICAL TRIAL NAVIGATOR
Get personalized assistance and answers to your clinical trial questions.
Learn MoreSign 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