Page Title
Clinical Trial Finder
Restore CFTR Protein Closed to Enrollment
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 will look at the safety and effectiveness of galicaftor/navocaftor/ABBV-576 combination therapy, a combination of CFTR modulators intended to help CFTR protein function closer to normal. This study is for adults with cystic fibrosis who have at least one F508del mutation.
Participants in arm 4 (cohort 3) will receive the galicaftor/navocaftor/ABBV-576 triple-combination therapy once daily for 28 days. All study participants will receive the study drug; there is no placebo used in arm 4 (cohort 3) of this trial. Researchers will test the effectiveness of the study medication by measuring sweat chloride and lung function. This study may require clinic visits, blood tests, lung function tests, an assessment for side effects, and completion of questionnaires.
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 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
Study Sites
-
Closed to Enrollment
California
Pediatric Diagnostic Center, Ventura, CA 93003
-
Closed to Enrollment
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
-
Closed to Enrollment
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
-
Closed to Enrollment
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
-
Closed to Enrollment
Missouri
Washington University School of Medicine, St. Louis, MO 63110
-
Closed to Enrollment
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
-
Closed to Enrollment
New York
Albany Medical College, Albany, NY 12208
-
Closed to Enrollment
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
-
Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
-
Closed to Enrollment
Ohio
Toledo Children's Hospital, Toledo, OH 43606
-
Closed to Enrollment
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
-
Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
-
Closed to Enrollment
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
-
Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
-
Closed to Enrollment
South Carolina
Medical University of South Carolina, Charleston, SC 29425
-
Closed to Enrollment
Texas
University of Texas Southwestern, Dallas, TX 75390
-
Closed to Enrollment
Texas
University of Texas Health Center at Tyler, Tyler, TX 75708
-
Closed to Enrollment
Virginia
Virginia Commonwealth University, Richmond, VA 23298
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.
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