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Clinical Trial Finder
Genetic Therapy Enrolling
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.
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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
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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
Illinois
Northwestern University, Chicago, IL 60611
Contact
Rachel Nelson
Phone: +1 (312) 695-0415
Email: rachel.nelson@northwestern.edu
-
Enrolling
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling Soon
Louisiana
Tulane University, Metairie, LA 70006
Contact
Bailey Doctor
Phone: +1 (504) 988-8600
Email: bdoctor@tulane.edu
-
Enrolling Soon
Maryland
Johns Hopkins University, Baltimore, MD 21287
Contact
Jeanne Pinto
Phone: +1 (410) 955-9782
Email: jpinto4@jh.edu
-
Enrolling
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
-
Enrolling
New York
Columbia University Cystic Fibrosis Program, New York, NY 10032
Contact
Emily DiMango
Phone: +1 (212) 305-0290
Email: ead3@cumc.columbia.edu
-
Enrolling Soon
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
Contact
Nicole Hummel
Phone: +1 (513) 558-7036
Email: hummelne@ucmail.uc.edu
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Enrolling Soon
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
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Enrolling Soon
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
Contact
Dave Weaver
Phone: +1 (216) 445-6671
Email: weaverd@ccf.org
-
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
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.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 to 65 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For a more comprehensive list of eligibility criteria and details on this study, 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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