RecruitingPhase 2

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

United States33 participantsStarted 2024-12-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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

Exclusion criteria

✕. 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

What they're measuring

Incidence, severity and dose relationship of adverse events

Timeframe: Cohorts 1-3: 16 weeks and Cohort 4: 24 weeks

Trial details

NCT IDNCT06747858

SponsorArcturus Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Clinical Trial Disclosure Manager Central Email Box

858-900-2660 CFclinicaltrials@arcturusrx.com

View on ClinicalTrials.gov More Cystic Fibrosis trials