Tests ARCT-032 in adults with cystic fibrosis who cannot take CFTR modulators
Tests ARCT-032 in adults with cystic fibrosis who cannot use modulator drugs.
Plain-language title generated from the registry record
Registry title: Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Key facts
- Where
- Boston, Charleston, Cleveland, Hollywood, Little Rock, Los Angeles, Nashville, Northfield, San Antonio, Seattle, St Louis, Tucson, and Washington D.C., United StatesSee the 13 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cystic fibrosis who cannot use or are not taking CFTR modulator medicines. They would inhale the study drug ARCT-032.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed cystic fibrosis. FEV1 (a lung function test) of 40% to 100% of predicted value in cohorts 1-3, and 45% to 90% in cohort 4.
- Earlier treatment
- Not able to have CFTR modulator therapy, or not taking CFTR modulators for at least 60 days before the first dose (for example because of intolerance, poor response, or no access).
Main reasons for not taking part
- Illness or medical condition that could add risk or confuse the study results
- Recent moderate or severe coughing up of blood (hemoptysis)
- Recent major surgery
- Solid organ or blood-related transplant
- Need for extra oxygen while awake, or more than 2L per minute while sleeping
Read by machine on 9 November 2026.
Where in United States
- Boston Children's HospitalBoston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
- University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
- Children's Hospital of Los AngelesLos Angeles, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- The Cystic Fibrosis InstituteNorthfield, United StatesNo longer taking part
- UT Health San AntonioSan Antonio, United StatesTaking people
- Seattle Children's HospitalSeattle, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- University of ArizonaTucson, United StatesTaking people
- Children's National HospitalWashington D.C., United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arcturus Therapeutics, Inc.
- Trial code
- NCT06747858EU 2024-517663-23-01
- Record updated
- 8 May 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis
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.
Inclusion: Confirmed diagnosis of Cystic Fibrosis; 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); FEV1 between 40% to 100% (cohorts 1-3) and 45% to 90% (cohort 4, inclusive) of predicted value for age, sex and height.
Exclusion: Recent major surgery; Solid organ or hematologic transplant; Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day; History of illness or medical condition that might pose an additional risk or may confound study results; Recent moderate or severe hemoptysis; Requirement of supplemental oxygen while awake or > 2L per minute while sleeping; Adequate liver and kidney function as determined by lab tests.