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โ† Trials
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Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis

RecruitingPhase 2Ages 18 Years - anyAllArcturus Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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% to 100% (cohorts 1-3) and 45% to 90% (cohort 4, inclusive) of predicted value for age, sex and height 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
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What it tests

  • ARCT-032
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Where

13 sites
University of Arizona
Tucson, United States
University of Arkansas for Medical Sciences
Little Rock, United States
Children's Hospital of Los Angeles
Los Angeles, United States
Children's National Hospital
Washington D.C., United States
Joe DiMaggio Children's Hospital
Hollywood, United States
The Cystic Fibrosis Institute
Northfield, United States
Boston Children's Hospital
Boston, United States
Washington University School of Medicine
St Louis, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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