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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Arcturus Therapeutics, Inc.
Study ID
NCT06747858
Phase
PHASE2
Status
Recruiting
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Conditions

  • CFTR Gene Mutation
  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARCT-032 — BIOLOGICAL
    CFTR mRNA formulated in lipid nanoparticles

Study Details

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.

Key Dates

Start date
Dec 12, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Dose Level A of ARCT-032, inhaled daily for 28 days
  • Experimental: Cohort 2
    Dose Level B of ARCT-032, inhaled daily for 28 days
  • Experimental: Cohort 3
    Dose Level C of ARCT-032, inhaled daily for 28 days
  • Experimental: Cohort 4
    Dose level B or C of ARCT-032, inhaled once daily for 12 weeks

Primary Outcome Measure

Incidence, severity and dose relationship of adverse events [ Time Frame: Cohorts 1-3: 16 weeks and Cohort 4: 24 weeks ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724-
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Children's National HospitalWashington D.C.District of Columbia20010-
Joe DiMaggio Children's HospitalHollywoodFlorida33021-
The Cystic Fibrosis InstituteNorthfieldIllinois60093-
Boston Children's HospitalBostonMassachusetts02115-
Washington University School of MedicineSt LouisMissouri63144-
Cleveland Clinic FoundationClevelandOhio44195-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Vanderbilt University Medical CenterNashvilleTennessee37232-
UT Health San AntonioSan AntonioTexas78229-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARChildren's Hospital of Los Angeles· Los Angeles, CAChildren's National Hospital· Washington D.C., DCJoe DiMaggio Children's Hospital· Hollywood, FLThe Cystic Fibrosis Institute· Northfield, IL

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