Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06747858

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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2
3
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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

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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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