Back to Trials
NCT06747858PHASE2Recruiting

Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis

Arcturus Therapeutics, Inc.

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

Key Inclusion Criteria: 1. Confirmed diagnosis of Cystic Fibrosis 2. Not eligible for CFTR modulator therapy or not taking CFTR modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators) 3. FEV1 between 40% to 100% (cohorts 1-3) and 45% to 90% (cohort 4, inclusive) of predicted value for age, sex and height Exclusion Criteria: 1. History of illness or medical condition that might pose an additional risk or may confound study results 2. Recent moderate or severe hemoptysis 3. Recent major surgery 4. Solid organ or hematologic transplant 5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping. 6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day 7. Adequate liver and kidney function as determined by lab tests

Interventions

BIOLOGICAL

ARCT-032

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Cystic FibrosisCFTR Gene Mutation

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