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Genetic Therapy Closed to Enrollment
Study to evaluate SP-101 in adults with cystic fibrosis who are ineligible for or cannot tolerate CFTR modulator therapy. (Spirovant CFAAV-001 US)
This study will evaluate the safety and tolerability of SP-101, an inhaled gene therapy, in adults with cystic fibrosis ages 18 to 65 who are ineligible for or cannot tolerate CFTR modulator therapy.
This is an open label study, meaning all participants will receive a dose of the study drug. Two different doses are being studied. SP-101 is a gene therapy intended to provide a new, correct copy of the CFTR gene to lung cells. Study participants will receive one dose of the study drug and then have follow-up study visits or phone calls for one year. Participants will have their health status followed for an additional 48 months after completion of this study.
This study may require blood draws, lung function testing, electrocardiograms, and/or other measurements.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years to 65 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Most participants in this study will not be eligible for CFTR modulators or will have discontinued them. Some people who are still taking CFTR modulators but have experienced a less than 5 percentage point improvement with modulators may also be eligible later in the study. .
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
1 years -
Number of Study Visits:
11
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Spirovant Sciences -
Study Drugs:
Study Sites
-
Closed to Enrollment
Illinois
Northwestern University, Chicago, IL 60611
-
Closed to Enrollment
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
-
Closed to Enrollment
Louisiana
Tulane University, Metairie, LA 70006
-
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
Nebraska
University of Nebraska Medical Center, Omaha, NE 68198
-
Closed to Enrollment
New York
Columbia University Cystic Fibrosis Program, New York, NY 10032
-
Closed to Enrollment
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
-
Closed to Enrollment
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
-
Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
-
Closed to Enrollment
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years to 65 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Most participants in this study will not be eligible for CFTR modulators or will have discontinued them. Some people who are still taking CFTR modulators but have experienced a less than 5 percentage point improvement with modulators may also be eligible later in the study. .
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