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RNA-based Therapy
ARCT-032 for Cystic Fibrosis (LunairCF Trial)
Northfield, IL
Phase 2
Recruiting
Research Sponsored by Arcturus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of Cystic Fibrosis
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called ARCT-032 in adults with cystic fibrosis who cannot take other standard treatments.
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Who is the study for?
This trial is for adults with Cystic Fibrosis who can't use CFTR modulator therapy because it doesn't work for them, they can't tolerate it, or they don't have access. Participants should not currently be on any CFTR modulators.Check my eligibility
What is being tested?
The study is testing multiple doses of a new drug called ARCT-032 to see how safe and effective it is for treating Cystic Fibrosis in adults. It's an open-label and multicenter trial, meaning both the researchers and participants know what treatment is being given.See study design
What are the potential side effects?
Since this summary does not provide specific side effects of ARCT-032, we cannot detail them here. Generally, potential side effects could range from mild reactions at the injection site to more serious impacts on liver function or digestion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Cystic Fibrosis.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need extra oxygen when awake or more than 2L/min when sleeping.
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Select...
I take more than 15 mg of corticosteroids daily.
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Select...
I have had a solid organ or bone marrow transplant.
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Select...
I have recently coughed up a noticeable amount of blood.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence, severity and dose relationship of adverse events
Secondary study objectives
Pharmacodynamics--Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R)
Pharmacodynamics--Lung Function
Pharmacokinetics
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Dose Level C of ARCT-032, inhaled daily for 28 days
Group II: Cohort 2Experimental Treatment1 Intervention
Dose Level B of ARCT-032, inhaled daily for 28 days
Group III: Cohort 1Experimental Treatment1 Intervention
Dose Level A of ARCT-032, inhaled daily for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARCT-032
2023
Completed Phase 1
~40
Find a Location
Closest Location:The Cystic Fibrosis Institute· Northfield, IL· 290 miles
Who is running the clinical trial?
Arcturus Therapeutics, Inc.Lead Sponsor
13 Previous Clinical Trials
22,270 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
39 Patients Enrolled for Cystic Fibrosis