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Restore CFTR Function Enrolling
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.
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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
-
Enrolling Soon
California
Pediatric Diagnostic Center, Ventura, CA 93003
Contact
Chris Landon
Phone: +1 (805) 652-6255
Email: chris.landon@ventura.org
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Enrolling Soon
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
Contact
Lynn Fukushima
Phone: +1 (323) 409-5383
Email: lynn.fukushima@med.usc.edu
-
Enrolling Soon
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kathleen Summo
Phone: +1 (407) 841-1100
Email: ksummo@cfpulmonary.com
-
Enrolling Soon
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling Soon
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
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Enrolling Soon
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
Contact
Debra Driscoll
Phone: +1 (313) 745-2221
Email: ddriscol@med.wayne.edu
-
Enrolling
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
Contact
Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
-
Enrolling
New York
Albany Medical College, Albany, NY 12208
Contact
Anne Denero
Phone: +1 (518) 262-5196
Email: DeneroA@mail.amc.edu
-
Enrolling
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
Contact
Cara Fidnarick
Phone: +1 (516) 465-5400
Email: cfidnari@northwell.edu
-
Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
-
Enrolling
Ohio
Toledo Children's Hospital, Toledo, OH 43606
Contact
Kelly Hoot
Phone: +1 (419) 291-4630
Email: kelly.hoot@promedica.org
-
Enrolling Soon
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
Contact
Nicole Hummel
Phone: +1 (513) 558-7036
Email: hummelne@ucmail.uc.edu
-
Enrolling
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
-
Enrolling Soon
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Contact
Diane Kitch
Phone: +1 (717) 531-5646
Email: dkitch@pennstatehealth.psu.edu
-
Enrolling Soon
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling Soon
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-6233
Email: Ashley.Keller@UTSouthwestern.edu
-
Enrolling Soon
Texas
University of Texas Health Center at Tyler, Tyler, TX 9038775271
Contact
Debbie Fielder
Phone: +1 (903) 877-7753
Email: debbie.fielder@uthct.edu
-
Enrolling Soon
Virginia
Virginia Commonwealth University, Richmond, VA 23298
Contact
Margaret (Meg) Lessard
Phone: +1 (804) 628-3093
Email: margaret.lessard@vcuhealth.org
-
Enrolling Soon
Wisconsin
Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226
Contact
Erin Hubertz
Phone: +1 (414) 955-7019
Email: ehubertz@mcw.edu
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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.
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