Loading clinical trials...

Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis

NCT06747858•Arcturus Therapeutics, Inc.

View on ClinicalTrials.gov

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 will receive nebulized ARCT-032 daily for 4 weeks, and then followed for safety for a total of 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Confirmed diagnosis of Cystic Fibrosis

Exclusion Criteria

•3. FEV1 between 40% and 100% of predicted value
•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

Locations (11)

University of Arizona

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Central Florida Pulmonary Group

Orlando, Florida, United States

The Cystic Fibrosis Institute

Northfield, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Vanderbilt University

Nashville, Tennessee, United States

UT Health

San Antonio, Texas, United States

Key Dates

Start Date

December 12, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

October 9, 2025

Enrollment

ESTIMATED participants

Conditions

Cystic FibrosisCFTR Gene Mutation

Interventions

ARCT-032

BIOLOGICAL

Contacts

Clinical Trial Disclosure Manager Central Email Box

CONTACT

858-900-2660 CFclinicaltrials@arcturusrx.com

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population