Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis

Launched by ARCTURUS THERAPEUTICS, INC. · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ARCT-032 for adults with Cystic Fibrosis (CF), a genetic condition that affects the lungs and digestive system. The trial focuses on people who are not currently using CFTR modulators—medications that help manage CF—either because they can't take them, they didn't work for them, or they can't access them. The goal is to determine how safe ARCT-032 is, how well patients tolerate it, and if it can be effective in improving their condition.

To be eligible for this study, participants need to have a confirmed diagnosis of Cystic Fibrosis, and they must have a lung function test result between 40% and 100% of what is expected for their age. Importantly, they should not have taken CFTR modulators for at least 60 days prior to starting the trial. Participants will be monitored closely throughout the trial to assess their safety and response to the treatment. This study is currently recruiting participants, and it offers an opportunity for individuals who have limited options for managing their Cystic Fibrosis.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Confirmed diagnosis of Cystic Fibrosis
• • 2. 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).
• • 3. FEV1 between 40% and 100% of predicted value
• Exclusion Criteria:
• • 1. History of illness or medical condition that might pose an additional risk or may confound study results
• • 2. Recent moderate or severe hemoptysis
• • 3. Recent major surgery
• • 4. Solid organ or hematologic transplant
• • 5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping.
• • 6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
• • 7. Adequate liver and kidney function as determined by lab tests