Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Start Date
12/12/2024
Completion Date
6/1/2027
Summary
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.
Detailed Description
This is an open-label, multiple-ascending dose study of ARCT-032 in adults with CF who are not on CFTR modulator therapy. After successful screening, eligible participants enrolled in cohorts 1-3 will receive nebulized ARCT-032 daily for 4 weeks and then will be followed for safety for a total of 12 weeks. In cohort 4, eligible participants will receive nebulized ARCT-032 for 12 weeks and will then be followed for safety for an additional 12 weeks.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ARCT-032
Conditions
Locations
University of Arizona
Tucson, Arizona 85724
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
Children's Hospital of Los Angeles
Los Angeles, California 90027
United States
Children's National Hospital
Washington D.C., District of Columbia 20010
United States
Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
The Cystic Fibrosis Institute
Northfield, Illinois 60093
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Washington University School of Medicine
St Louis, Missouri 63144
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
UT Health San Antonio
San Antonio, Texas 78229
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States