Recruiting
Phase 2

ARCT-032

Sponsor:

Arcturus Therapeutics, Inc.

Code:

NCT06747858

Conditions

Cystic Fibrosis

CFTR Gene Mutation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARCT-032

Study Details

Brief 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.

Conditions

Cystic Fibrosis

CFTR Gene Mutation

Study ID

NCT06747858

Start date

Dec 12, 2024

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Dose Level A of ARCT-032, inhaled daily for 28 days

experimental: Cohort 2

Dose Level B of ARCT-032, inhaled daily for 28 days

experimental: Cohort 3

Dose Level C of ARCT-032, inhaled daily for 28 days

experimental: Cohort 4

Dose level B or C of ARCT-032, inhaled once daily for 12 weeks

Interventions

ARCT-032

CFTR mRNA formulated in lipid nanoparticles

Primary outcome measure

  • Incidence, severity and dose relationship of adverse events [ Time Frame: Cohorts 1-3: 16 weeks and Cohort 4: 24 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure Manager Central Email Box

858-900-2660CFclinicaltrials@arcturusrx.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63144

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Arcturus Therapeutics, Inc.

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • CFTR
  • mRNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arcturus Therapeutics, Inc. on 2026-05-08.