Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT06102005
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 685}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized rate of asthma exacerbation events', 'timeFrame': 'From baseline to week 48'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in pre-bronchodilator (BD) FEV1', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Change from baseline in post-BD FEV1', 'timeFrame': 'From baseline to week 48'}, {'measure': 'The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score', 'timeFrame': 'From baseline to week 48', 'description': 'ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control'}, {'measure': 'Change from baseline in ACQ-5 score', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Change from baseline in FeNO', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Time to first asthma exacerbation', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief', 'timeFrame': 'From baseline to week 48'}, {'measure': "Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores", 'timeFrame': 'From baseline to week 48', 'description': 'Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.'}, {'measure': 'Proportion of participants with ≥4-point improvement in SGRQ score', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Change from baseline in ACQ scores', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score', 'timeFrame': 'From baseline to week 48'}, {'measure': 'Serum lunsekimig concentrations', 'timeFrame': 'From baseline to week 52'}, {'measure': 'Anti-drug antibodies (ADA) against lunsekimig', 'timeFrame': 'From baseline to week 52'}, {'measure': 'Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)', 'timeFrame': 'From baseline to week 52'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5\n* Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1\n* At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy\n* ACQ-5 score more than 1.5 at Screening (Visit 1)\n\nExclusion Criteria:\n\n* Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.\n* Current smoker or former smoker with cessation within 6 months of Screening or history of \\>10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.\n* Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening\n* Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening\n* For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).\n* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening\n* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"}, 'identificationModule': {'nctId': 'NCT06102005', 'acronym': 'AIRCULES', 'briefTitle': 'Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma', 'orgStudyIdInfo': {'id': 'DRI16762'}, 'secondaryIdInfos': [{'id': 'U1111-1280-5514', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2023-503712-33', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lunsekimig Dose1 interval 1', 'description': 'Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1', 'interventionNames': ['Drug: Lunsekimig']}, {'type': 'EXPERIMENTAL', 'label': 'Lunsekimig Dose 1 interval 2', 'description': 'Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2', 'interventionNames': ['Drug: Lunsekimig']}, {'type': 'EXPERIMENTAL', 'label': 'Lunsekimig Dose 2 interval 1', 'description': 'Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1', 'interventionNames': ['Drug: Lunsekimig']}, {'type': 'EXPERIMENTAL', 'label': 'Lunsekimig Dose 2 interval 2', 'description': 'Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2', 'interventionNames': ['Drug: Lunsekimig']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lunsekimig', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution for injection Route of administration: subcutaneous', 'armGroupLabels': ['Lunsekimig Dose 1 interval 2', 'Lunsekimig Dose 2 interval 1', 'Lunsekimig Dose 2 interval 2', 'Lunsekimig Dose1 interval 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution for injection Route of administration: subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Allergy, Asthma & Immunology Associates- Site Number : 8400009', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'facility': 'Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Antelope Valley Clinical Trials- Site Number : 8400020', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Optimus Medical- Site Number : 8400046', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Allianz Research Institute CO- Site Number : 8400026', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Velocity Clinical Research - Denver- Site Number : 8400027', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western States Clinical Research- Site Number : 8400014', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '33157', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Beautiful Minds Clinical Research Center- Site Number : 8400049', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33010', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Qway Research - Hialeah- Site Number : 8400015', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clintex Research Group - Miami - Coral Way- Site Number : 8400048', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33184', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'High Quality Research- Site Number : 8400039', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovations Biotech- Site Number : 8400040', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Access Medical Center- Site Number : 8400043', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Deluxe Health Center- Site Number : 8400045', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34653', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research Institute - New Port Richey- Site Number : 8400044', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Pines Care Research Center- Site Number : 8400057', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30701', 'city': 'Calhoun', 'state': 'Georgia', 'country': 'United States', 'facility': 'Appalachian Clinical Research- Site Number : 8400050', 'geoPoint': {'lat': 34.50259, 'lon': -84.95105}}, {'zip': '61822', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'PMG Research of Christie Clinic- Site Number : 8400066', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Velocity Clinical Research Lafayette Site Number : 8400060', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Javara - Privia Medical Group - Annapolis- Site Number : 8400033', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital- Site Number : 8400034", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System - Ann Arbor- Site Number : 8400004', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Javara - Mankato Clinic- Site Number : 8400051', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Clinical Research Center - St. Louis- Site Number : 8400006', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10940', 'city': 'Middletown', 'state': 'New York', 'country': 'United States', 'facility': 'Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai- Site Number : 8400058', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28273', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Research - Charlotte- Site Number : 8400071', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28287', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research Of Gastonia- Site Number : 8400013', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bernstein Clinical Research Center- Site Number : 8400016', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Asthma & Allergy Center - Toledo- Site Number : 8400017', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OK Clinical Research- Site Number : 8400021', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Velocity Clinical Research - Medford- Site Number : 8400059', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '15801', 'city': 'DuBois', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Associates of Central PA - Dubois- Site Number : 8400069', 'geoPoint': {'lat': 41.11923, 'lon': -78.76003}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19464', 'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064', 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'VitaLink Research - Anderson - East Greenville- Site Number : 8400063', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Velocity Clinical Research - Charleston- Site Number : 8400061', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Orion Clinical Research- Site Number : 8400001', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78006', 'city': 'Boerne', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Medical Research Institute - TTS Research- Site Number : 8400010', 'geoPoint': {'lat': 29.79466, 'lon': -98.73197}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center- Site Number : 8400002', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79903', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Western Sky Medical Research- Site Number : 8400023', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75069', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Pulmonary and Sleep Center- Site Number : 8400022', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'VAST Clinical Research- Site Number 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