NCT06747858RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 17 Dec 2024
- Start date
- 12 Dec 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Arcturus Therapeutics, Inc.
- Diseases
- Cystic fibrosis
- NCT number
- NCT06747858
- EU CT number
- 2024-517663-23-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 12 Dec 2024 to the primary completion date, Jun 2027
- 17 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of illness or medical condition that might pose an additional risk or may confound study results
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| National Institute Of Tuberculosis And Lung Diseases Coordinator of this site? Confirm its status | Rabka-Zdroj | Poland | Completed |
| Podkarpacki Osrodek Pulmunologii I Alergologii Sp. z o. o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Completed |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Children's Hospital of Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| The Cystic Fibrosis Institute Coordinator of this site? Confirm its status | Northfield | United States | Active, not recruiting |
| UT Health San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.