Actively Recruiting
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Led by Arcturus Therapeutics, Inc. · Updated on 2026-05-08
33
Participants Needed
13
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Cystic Fibrosis
- Not eligible for CFTR modulator therapy or not taking CFTR modulators for at least 60 days prior to dosing due to intolerance, poor response, or lack of access
- FEV1 between 40% to 100% of predicted value for age, sex, and height for cohorts 1-3
- FEV1 between 45% to 90% of predicted value for age, sex, and height for cohort 4
You will not qualify if you...
- History of illness or medical condition posing additional risk or confounding study results
- Recent moderate or severe hemoptysis
- Recent major surgery
- Solid organ or hematologic transplant
- Requirement of supplemental oxygen while awake or more than 2 liters per minute while sleeping
- Chronic maintenance systemic corticosteroids exceeding 15 mg oral prednisone daily or 30 mg every other day
- Inadequate liver or kidney function based on lab tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
5
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
6
The Cystic Fibrosis Institute
Northfield, Illinois, United States, 60093
Active, Not Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63144
Actively Recruiting
9
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
13
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
C
Clinical Trial Disclosure Manager Central Email Box
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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