Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-22 @ 8:50 AM
Study NCT ID:
NCT06747858
Status:
RECRUITING
Last Update Posted:
2025-10-09
First Post:
2024-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Multiple ascending dose'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity and dose relationship of adverse events', 'timeFrame': '16 weeks', 'description': 'Safety and tolerability of ARCT-032 assess by determining incidence, severity and dose-relationship of AEs by dose level'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Up to 6 weeks', 'description': 'Plasma concentration of ARCT-032 mRNA and lipid components'}, {'measure': 'Pharmacodynamics--Lung Function', 'timeFrame': '4 weeks', 'description': 'Change from baseline in FEV1'}, {'measure': 'Pharmacodynamics--Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in CFQ-R RSS (Respiratory Symptoms Scale) Score. Overall CFQ-R score ranges from 0-100, with higher scores indicating better health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CFTR', 'mRNA'], 'conditions': ['Cystic Fibrosis', 'CFTR Gene Mutation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is an open-label, multiple-ascending dose study of ARCT-032 in adults with CF who are not on CFTR modulator therapy. After successful screening, eligible participants will receive nebulized ARCT-032 daily for 4 weeks, and then followed for safety for a total of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Confirmed diagnosis of Cystic Fibrosis\n2. 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).\n3. FEV1 between 40% and 100% of predicted value\n\nExclusion Criteria:\n\n1. History of illness or medical condition that might pose an additional risk or may confound study results\n2. Recent moderate or severe hemoptysis\n3. Recent major surgery\n4. Solid organ or hematologic transplant\n5. Requirement of supplemental oxygen while awake or \\> 2L per minute while sleeping.\n6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day\n7. Adequate liver and kidney function as determined by lab tests'}, 'identificationModule': {'nctId': 'NCT06747858', 'acronym': 'LunairCF', 'briefTitle': 'Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcturus Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'ARCT-032-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Dose Level A of ARCT-032, inhaled daily for 28 days', 'interventionNames': ['Biological: ARCT-032']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Dose Level B of ARCT-032, inhaled daily for 28 days', 'interventionNames': ['Biological: ARCT-032']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Dose Level C of ARCT-032, inhaled daily for 28 days', 'interventionNames': ['Biological: ARCT-032']}], 'interventions': [{'name': 'ARCT-032', 'type': 'BIOLOGICAL', 'description': 'CFTR mRNA formulated in lipid nanoparticles', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Joe DiMaggio Children's Hospital", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Central Florida Pulmonary Group', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60093', 'city': 'Northfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Cystic Fibrosis Institute', 'geoPoint': {'lat': 42.09975, 'lon': -87.7809}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UT Health', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Clinical Trial Disclosure Manager Central Email Box', 'role': 'CONTACT', 'email': 'CFclinicaltrials@arcturusrx.com', 'phone': '858-900-2660'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcturus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}