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Restore CFTR Protein Closed to Enrollment
Study of ELX-02 in adults with cystic fibrosis who have at least one G542X mutation (Eloxx EL-012 - Cohorts 1 to 4)
This study will look at the safety and tolerability of ELX-02 and how the body processes the drug, a molecule intended to restore CFTR function. Multiple doses of ELX-02 will be tested in adults with cystic fibrosis who have at least one G542X mutation.
This is an open-label study, meaning that all participants will receive increasing doses of the drug ELX-02 over four treatment periods. Researchers will test the safety and tolerability of ELX-02 by tracking adverse events and other changes in the body. They will assess how the body processes ELX-02 by monitoring how much of the drug stays in the body. They will also study the drug’s effect on the body by tracking changes in lung function and sweat chloride.This study may require blood draws, lung function tests, and/or sweat tests.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Copies F508del -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have at least one G542X mutation. The second mutation can be any Class 1 or Class 2 mutation excluding F508del. Participants with one G542X allele and a second allele that is not a Class 1 or Class 2 mutation potentially may be allowed. Participants must not have taken CFTR modulator therapies for at least 60 days prior to study treatment.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
15 weeks -
Number of Study Visits:
15
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Eloxx Pharmaceuticals Inc. -
Study Drugs:
Study Sites
-
Closed to Enrollment
California
Stanford University Medical Center, Palo Alto, CA 94304
-
Closed to Enrollment
California
Long Beach Memorial Medical Center, Long Beach, CA 90806
-
Closed to Enrollment
Colorado
National Jewish Health, Denver, CO 80206
-
Closed to Enrollment
Maryland
Johns Hopkins University, Baltimore, MD 21287
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
-
Closed to Enrollment
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
-
Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Copies F508del -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have at least one G542X mutation. The second mutation can be any Class 1 or Class 2 mutation excluding F508del. Participants with one G542X allele and a second allele that is not a Class 1 or Class 2 mutation potentially may be allowed. Participants must not have taken CFTR modulator therapies for at least 60 days prior to study treatment.
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