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Clinical Trial Finder
Genetic Therapy Enrolling
Study of ARCT-032 in adults with cystic fibrosis who are not on CFTR modulator therapy. (Arcturus ARCT-032-02 Cohort 4)
This study will test the safety, tolerability and effectiveness of ARCT-032, a nebulized therapy intended to deliver a new, correct copy of CFTR messenger RNA (mRNA) to cells.
This is an open label study. This means that all participants will receive the study drug (nebulized ARCT-032) for 12 weeks and will be followed for an additional 12 weeks. Researchers will measure safety and tolerability by monitoring for adverse events and changes in laboratory test results. Additionally, the effect of ARCT-032 on lung function and quality of life will be assessed.
This study may require physical exams, lung function tests, blood draws, questionnaires, 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 and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
45 to 90%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants will either have mutations that are not eligible to receive CFTR modulator therapy or are no longer taking CFTR modulator therapy due to intolerance or other reasons.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
24 weeks -
Number of Study Visits:
13
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Arcturus -
Study Drugs:
Study Sites
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Enrolling Soon
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Elizabeth Ryan
Phone: +1 (520) 626-3125
Email: elizabethryan@arizona.edu
-
Enrolling
Arkansas
University of Arkansas for Medical Sciences, Little Rock, AR 72205
Contact
Kathleen Hicks
Phone: +1 (501) 686-5527
Email: HicksKathleenT@uams.edu
-
Enrolling
California
Children's Hospital of Los Angeles, Los Angeles, CA 90027
Contact
Carmen Reyes
Phone: +1 (323) 361-2662
Email: mareyes@chla.usc.edu
-
Enrolling Soon
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Desiree Serr
Phone: +1 (407) 303-7192
Email: desiree.serr1@adventhealth.com
-
Enrolling Soon
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
Contact
Norma (Jean) Barton
Phone: +1 (954) 276-9350
Email: nbarton@mhs.net
-
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
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling Soon
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
Contact
Dave Weaver
Phone: +1 (216) 538-9524
Email: weaverd@ccf.org
-
Enrolling
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Sarah Shine
Phone: +1
Email: shinesa@musc.edu
-
Enrolling Soon
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
Contact
Brijesh Patel
Phone: +1 (615) 343-4865
Email: brijesh.patel@vumc.org
-
Enrolling Soon
Washington
Seattle Children's Hospital, Seattle, WA 98115
Contact
Dawn Batchuluun
Phone: +1 (206) 987-0806
Email: Dawn.Batchuluun@seattlechildrens.org
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):
No Mutation Requirement -
FEV1% Predicted:
45 to 90%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants will either have mutations that are not eligible to receive CFTR modulator therapy or are no longer taking CFTR modulator therapy due to intolerance or other reasons.
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