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Tests treatment safety and results for Cystic Fibrosis
Official title Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
ClinicalTrials.gov ID: NCT06747858
What this study is testing
What is ARCT-032?
ARCT-032 is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for cystic fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- FEV1 between 40% to 100% (cohorts 1-3) and 45% to 90% (cohort 4, inclusive) of predicted value for age, sex and height
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Hollywood, Florida, United States
- Northfield, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Hollywood, Florida, United States; Northfield, Illinois, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.