Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
LunairCF
A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis
1 other identifier
interventional
12
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2024
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2024
CompletedFirst Submitted
Initial submission to the registry
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
December 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 9, 2025
October 1, 2025
12 months
December 17, 2024
October 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence, severity and dose relationship of adverse events
Safety and tolerability of ARCT-032 assess by determining incidence, severity and dose-relationship of AEs by dose level
16 weeks
Secondary Outcomes (3)
Pharmacokinetics
Up to 6 weeks
Pharmacodynamics--Lung Function
4 weeks
Pharmacodynamics--Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R)
4 weeks
Study Arms (3)
Cohort 1
EXPERIMENTALDose Level A of ARCT-032, inhaled daily for 28 days
Cohort 2
EXPERIMENTALDose Level B of ARCT-032, inhaled daily for 28 days
Cohort 3
EXPERIMENTALDose Level C of ARCT-032, inhaled daily for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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% and 100% of predicted value
You may not qualify if:
- History of illness or medical condition that might pose an additional risk or may confound study results
- Recent moderate or severe hemoptysis
- Recent major surgery
- Solid organ or hematologic transplant
- Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping.
- Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
- Adequate liver and kidney function as determined by lab tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Central Florida Pulmonary Group
Orlando, Florida, 32803, United States
The Cystic Fibrosis Institute
Northfield, Illinois, 60093, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Washington University
St Louis, Missouri, 63144, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
UT Health
San Antonio, Texas, 78229, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Clinical Trial Disclosure Manager Central Email Box
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2024
First Posted
December 24, 2024
Study Start
December 12, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share