[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06191315":3,"trial-entities:NCT06191315":684,"trial-summary:NCT06191315":689},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":51,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":15,"eligibility_criteria":112,"std_ages":129,"locations":131,"central_contacts":680,"overall_officials":681,"references":682,"see_also_links":683},"NCT06191315","EFC14771","Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma\u002FAsthmatic Wheeze Aged 2 to \u003C6 Years (LIBERTY ASTHMA TREKIDS)","A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to \u003C6 Years of Age With Uncontrolled Asthma and\u002For Recurrent Severe Asthmatic Wheeze","ENROLLING_BY_INVITATION","2028-12-21","2026-08","2026-08-13","2024-01-03","Sanofi","INDUSTRY",false,"This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \\\u003C6 years of age with uncontrolled asthma and\u002For recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \\\u003C6 years old with uncontrolled asthma and\u002For recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.\n\nStudy details include:\n\nPart A:\n\nThe study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).\n\nPart B:\n\nFor participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \\[4-week Screening and a 52-week treatment period\\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).","The duration per participant is up to 120 Weeks.",[19,20],"Wheezing","Asthma",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},90,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Dupilumab","Pharmaceutical form: Injection solution Route of administration: Subcutaneous",[35],"Dupilumab (double-blind period)",[37,38],"SAR231893","Dupixent",{"type":31,"name":40,"description":33,"armGroupLabels":41},"Placebo",[40],[43,47],{"measure":44,"description":45,"timeFrame":46},"Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period","Annualized rate of severe asthma exacerbations during the 52-week treatment period.","Baseline through Week 52",{"measure":48,"description":49,"timeFrame":50},"Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation","Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.","Week 52 through Week 116",[52,54,57,59,62,65,68,70,73,77,80,83,86,89,92,95,97,99,101,105,107],{"measure":53,"timeFrame":46},"Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period.",{"measure":55,"description":56,"timeFrame":46},"Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period","Annualized rate of moderate asthma exacerbations during the 52-week treatment period.",{"measure":58,"timeFrame":46},"Part A: Cumulative ICS dose during the 52-week treatment period",{"measure":60,"timeFrame":61},"Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period","Baseline to Week 52",{"measure":63,"description":64,"timeFrame":46},"Part A: Mean number of days without asthma symptoms (DWAS) using the Pediatric Asthma Caregiver Diary (PACD) during the 52-week treatment period","A day without asthma symptoms (DWAS) is defined as a day without any asthma symptoms, β-agonist use, oral steroid use, or need for urgent asthma care. The PACD consists of a daytime and overnight record. The daytime asthma symptom questions are scored on a 6-point scale from 0 (no symptoms\u002Finterference) to 5 (very severe symptoms\u002Finterference). The overnight questions are scored on a 5-point scale from 0 (no overnight cough and caregiver not disturbed at all) to 4 (coughed all night and disturbed all night).",{"measure":66,"description":67,"timeFrame":61},"Part A: Change from baseline to Week 52 in daytime symptom score using the daytime record of PACD","The PACD consists of a daytime and overnight record. The daytime asthma symptom questions are scored on a 6-point scale from 0 (no symptoms\u002Finterference) to 5 (very severe symptoms\u002Finterference).",{"measure":69,"timeFrame":46},"Part A: Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation",{"measure":71,"description":72,"timeFrame":61},"Part A: Change from baseline to Week 52 in Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Scale","PedsQL measures health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Scores range 0-100 with higher scores indicate better HRQOL.",{"measure":74,"description":75,"timeFrame":76},"Part A: Caregiver Global Impression of Change in their child's asthma control (CGI-change in asthma control) at Week 52","CGI-change in asthma control is a 1-item questionnaire that asks the caregiver to provide the overall assessment of change of their child's asthma control on a 7-point scale, compared to just before he\u002Fshe started taking the study treatment. Response choices are: 0 = \"Very much better\", 1 =\"Moderately better\", 2 = \"A little better\", 3 = \"No change\", 4 = \"A little worse\", 5 = \"Moderately worse\", 6 = \"Very much worse\".","Week 52",{"measure":78,"description":79,"timeFrame":76},"Part A: Physician Global Assessment of Change of the child's asthma control (PGA-change in asthma control) at Week 52","The Physician Global Assessment of Change of Asthma (PGA-change in asthma control) is a 1 item questionnaire that asks the physician to provide the overall assessment of change in the child's asthma control on a 7-point scale, compared to just before he\u002Fshe started taking the study treatment. Response choices are: 0 = \"Very much better\", 1 = \"Moderately better\", 2 =\"A little better\", 3 = \"No change\", 4 = \"A little worse\", 5 = \"Moderately worse\", 6 = \"Very much worse\".",{"measure":81,"description":82,"timeFrame":61},"Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma control (CGI-asthma control)","The Caregiver Global Impression of asthma control (CGI-Asthma Control) is a 1-item questionnaire that asks caregiver to provide the assessment of their child's asthma control over the past 7 days, on a 4-point scale for the past week. Response choices are: 1 = \"Not controlled\", 2 = \"Somewhat controlled\", 3 = \"Moderately controlled\", 4 = \"Well controlled\".",{"measure":84,"description":85,"timeFrame":61},"Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma severity (CGI-asthma severity)","The Caregiver Global Impression of asthma severity (CGI-Asthma Severity) is a 1-item questionnaire that asks caregivers to provide the assessment of their child's asthma control over the past 7 days, on a 4-point scale for the past week. Response choices are: 1 = \"None\", 2 = \"Mild\", 3 = \"Moderate\", 4 = \"Severe\".",{"measure":87,"description":88,"timeFrame":61},"Part A: Change from baseline to Week 52 in Physician Global Assessment of the child's asthma control (PGA-asthma control).","The Physician Global Assessment of asthma control is a 1-item questionnaire that asks physicians to assess the control of the child's asthma in the past 7 days on a 4 point scale for the past week. Response choices are: 1 = \"Not controlled\", 2 = \"Somewhat controlled\", 3 = \"Moderately controlled\", 4 = \"Well controlled\".",{"measure":90,"description":91,"timeFrame":61},"Part A: Change from baseline to Week 52 in Test for Respiratory and Asthma Control in Kids (TRACK)","TRACK is a validated questionnaire for caregiver completion for preschool aged children with symptoms consistent with asthma. The total score range of 0 to 100. Higher scores indicated better asthma control.",{"measure":93,"timeFrame":94},"Part A: Change from baseline in blood eosinophil level at Weeks 24 and 52","Baseline to Week 24 and 52",{"measure":96,"timeFrame":46},"Part A: Concentration of dupilumab in serum over time during the 52-week treatment period",{"measure":98,"timeFrame":46},"Part A: Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab over time",{"measure":100,"timeFrame":46},"Part A: IgG response to any vaccination for tetanus, diphtheria and pertussis and antibody for influenza (HAI antibody titers) vaccine administered according to vaccination schedule during the 52-week treatment period",{"measure":102,"description":103,"timeFrame":104},"Part B: Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period","Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period.","Week 52 through Week 104",{"measure":106,"timeFrame":104},"Part B Concentration of dupilumab in serum over time during the 52-week Part B treatment period",{"measure":108,"timeFrame":104},"Part B: Incidence of treatment-emergent anti-drug antibodies (ADAs) against dupilumab over time","ALL","2 Years","5 Years",{"inclusion":113,"exclusion":122,"raw_text":128},[114,115,116,117,118,119,120,121],"Participant must be 2 to \\\u003C6 years of age","Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and\u002For recurrent severe asthmatic wheeze.","At least one additional major criterion from the modified asthma predictive index:","Parent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) willing and able to comply with clinic visits and study-related procedures.","Parent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) able to understand the study requirements.","Participants\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires","Body weight at screening and randomization \\>5 kg and \\\u003C30 kg.","Parents or caregivers or legal guardian capable of giving signed informed consent.",[123,124,125,126,127],"Severe asthma with the need for chronic oral\u002Fsystemic corticosteroid use (\\>1 month continuous) at the time of screening enrollment.","History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.","History of prematurity (\\\u003C34 weeks gestation).","Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.","History of life-threatening asthma (eg, requiring intubation).","Inclusion Criteria:\n\n* Participant must be 2 to \\\u003C6 years of age\n* Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and\u002For recurrent severe asthmatic wheeze.\n* At least one additional major criterion from the modified asthma predictive index:\n\n  1. Physician diagnosed Atopic Dermatitis,\n  2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU\u002FL).\n\n     OR 2 minor criteria:\n  3. Wheezing unrelated to colds,\n  4. Peripheral blood eosinophilia ≥4%,\n  5. Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE \\>0.35 kU\u002FL.\n* Parent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) willing and able to comply with clinic visits and study-related procedures.\n* Parent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) able to understand the study requirements.\n* Participants\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires\n* Body weight at screening and randomization \\>5 kg and \\\u003C30 kg.\n* Parents or caregivers or legal guardian capable of giving signed informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Severe asthma with the need for chronic oral\u002Fsystemic corticosteroid use (\\>1 month continuous) at the time of screening enrollment.\n* History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.\n* History of prematurity (\\\u003C34 weeks gestation).\n* Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.\n* History of life-threatening asthma (eg, requiring intubation).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",[130],"CHILD",[132,141,149,156,164,172,180,188,195,203,211,218,226,234,241,250,257,261,265,269,276,283,290,299,307,313,322,330,338,345,353,360,368,376,383,390,397,401,409,416,423,431,435,443,450,457,464,473,481,489,496,503,512,520,528,535,539,548,555,562,570,579,587,595,604,612,619,626,634,641,648,657,665,673],{"facility":133,"city":134,"state":135,"zip":136,"country":137,"geoPoint":138},"Phoenix Children's Hospital- Site Number : 8400001","Phoenix","Arizona","85016","United States",{"lat":139,"lon":140},33.44838,-112.07404,{"facility":142,"city":143,"state":144,"zip":145,"country":137,"geoPoint":146},"Allervie Clinical Research - Destin- Site Number : 8400016","Destin","Florida","32541",{"lat":147,"lon":148},30.39353,-86.49578,{"facility":150,"city":151,"state":144,"zip":152,"country":137,"geoPoint":153},"EMDA Clinical Research- Site Number : 8400026","Miami","33126",{"lat":154,"lon":155},25.77427,-80.19366,{"facility":157,"city":158,"state":159,"zip":160,"country":137,"geoPoint":161},"Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011","Chicago","Illinois","60611",{"lat":162,"lon":163},41.85003,-87.65005,{"facility":165,"city":166,"state":167,"zip":168,"country":137,"geoPoint":169},"Allergy and Asthma Specialist- Site Number : 8400002","Owensboro","Kentucky","42301",{"lat":170,"lon":171},37.77422,-87.11333,{"facility":173,"city":174,"state":175,"zip":176,"country":137,"geoPoint":177},"Mayo Clinic in Rochester - Minnesota- Site Number : 8400008","Rochester","Minnesota","55905",{"lat":178,"lon":179},44.02163,-92.4699,{"facility":181,"city":182,"state":183,"zip":184,"country":137,"geoPoint":185},"UBMD Pediatrics- Site Number : 8400013","Buffalo","New York","14203",{"lat":186,"lon":187},42.88645,-78.87837,{"facility":189,"city":190,"state":183,"zip":191,"country":137,"geoPoint":192},"Boston Children's Health Physicians - Hawthorne- Site Number : 8400010","Hawthorne","10532",{"lat":193,"lon":194},41.10732,-73.79597,{"facility":196,"city":197,"state":198,"zip":199,"country":137,"geoPoint":200},"UNC Children's Hospital- Site Number : 8400005","Chapel Hill","North Carolina","27514",{"lat":201,"lon":202},35.9132,-79.05584,{"facility":204,"city":205,"state":206,"zip":207,"country":137,"geoPoint":208},"Cincinnati Children's Hospital Medical Center- Site Number : 8400004","Cincinnati","Ohio","45229",{"lat":209,"lon":210},39.12711,-84.51439,{"facility":212,"city":213,"state":206,"zip":214,"country":137,"geoPoint":215},"University Hospitals Cleveland Medical Center- Site Number : 8400015","Cleveland","44106",{"lat":216,"lon":217},41.4995,-81.69541,{"facility":219,"city":220,"state":221,"zip":222,"country":137,"geoPoint":223},"Vanderbilt University Medical Center- Site Number : 8400024","Nashville","Tennessee","37232",{"lat":224,"lon":225},36.16589,-86.78444,{"facility":227,"city":228,"state":229,"zip":230,"country":137,"geoPoint":231},"South Texas Medical Research Institute - TTS Research- Site Number : 8400022","Boerne","Texas","78006",{"lat":232,"lon":233},29.79466,-98.73197,{"facility":235,"city":236,"state":229,"zip":237,"country":137,"geoPoint":238},"Texas Children's Hospital- Site Number : 8400027","Houston","77030",{"lat":239,"lon":240},29.76328,-95.36327,{"facility":242,"city":243,"state":244,"zip":245,"country":246,"geoPoint":247},"Investigational Site Number : 0320005","Rosario","Santa Fe Province","2000","Argentina",{"lat":248,"lon":249},-32.94682,-60.63932,{"facility":251,"city":252,"zip":253,"country":246,"geoPoint":254},"Investigational Site Number : 0320008","Buenos Aires","1028",{"lat":255,"lon":256},-34.61315,-58.37723,{"facility":258,"city":252,"zip":259,"country":246,"geoPoint":260},"Investigational Site Number : 0320003","1121",{"lat":255,"lon":256},{"facility":262,"city":252,"zip":263,"country":246,"geoPoint":264},"Investigational Site Number : 0320002","1122",{"lat":255,"lon":256},{"facility":266,"city":252,"zip":267,"country":246,"geoPoint":268},"Investigational Site Number : 0320001","1414",{"lat":255,"lon":256},{"facility":270,"city":271,"zip":272,"country":246,"geoPoint":273},"Investigational Site Number : 0320009","Corrientes","3400",{"lat":274,"lon":275},-27.46784,-58.8344,{"facility":277,"city":278,"zip":279,"country":246,"geoPoint":280},"Investigational Site Number : 0320006","Córdoba","5003",{"lat":281,"lon":282},-31.40648,-64.18853,{"facility":284,"city":285,"zip":286,"country":246,"geoPoint":287},"Investigational Site Number : 0320004","Mendoza","5500",{"lat":288,"lon":289},-32.88946,-68.84582,{"facility":291,"city":292,"state":293,"zip":294,"country":295,"geoPoint":296},"Hospital Ernesto Dornelles- Site Number : 0760004","Porto Alegre","Rio Grande do Sul","90160-093","Brazil",{"lat":297,"lon":298},-30.03283,-51.23019,{"facility":300,"city":301,"state":302,"zip":303,"country":295,"geoPoint":304},"Clinica de Alergia Martti Antila- Site Number : 0760002","Sorocaba","São Paulo","18040-425",{"lat":305,"lon":306},-23.50167,-47.45806,{"facility":308,"city":302,"zip":309,"country":295,"geoPoint":310},"Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001","05403-000",{"lat":311,"lon":312},-23.5475,-46.63611,{"facility":314,"city":315,"state":316,"zip":317,"country":318,"geoPoint":319},"Investigational Site Number : 1240002","Edmonton","Alberta","T6G 2B7","Canada",{"lat":320,"lon":321},53.55014,-113.46871,{"facility":323,"city":324,"state":325,"zip":326,"country":318,"geoPoint":327},"Investigational Site Number : 1240001","Vancouver","British Columbia","V6H 3N1",{"lat":328,"lon":329},49.24966,-123.11934,{"facility":331,"city":332,"state":333,"zip":334,"country":318,"geoPoint":335},"Investigational Site Number : 1240008","Burlington","Ontario","L7L 6W6",{"lat":336,"lon":337},43.38621,-79.83713,{"facility":339,"city":340,"state":333,"zip":341,"country":318,"geoPoint":342},"Investigational Site Number : 1240007","Hamilton","L8S 1G5",{"lat":343,"lon":344},43.25011,-79.84963,{"facility":346,"city":347,"state":348,"zip":349,"country":318,"geoPoint":350},"Investigational Site Number : 1240006","Montreal","Quebec","H3T 1C5",{"lat":351,"lon":352},45.50884,-73.58781,{"facility":354,"city":355,"state":348,"zip":356,"country":318,"geoPoint":357},"Investigational Site Number : 1240005","Sherbrooke","J1H 5N4",{"lat":358,"lon":359},45.40008,-71.89908,{"facility":361,"city":362,"zip":363,"country":364,"geoPoint":365},"Investigational Site Number : 2030001","Prague","190 00","Czechia",{"lat":366,"lon":367},50.08804,14.42076,{"facility":369,"city":370,"zip":371,"country":372,"geoPoint":373},"Investigational Site Number : 2500005","Créteil","94010","France",{"lat":374,"lon":375},48.79266,2.46569,{"facility":377,"city":378,"zip":379,"country":372,"geoPoint":380},"Investigational Site Number : 2500001","Lille","59000",{"lat":381,"lon":382},50.63391,3.05512,{"facility":384,"city":385,"zip":386,"country":372,"geoPoint":387},"Investigational Site Number : 2500004","Nice","06200",{"lat":388,"lon":389},43.70313,7.26608,{"facility":391,"city":392,"zip":393,"country":372,"geoPoint":394},"Investigational Site Number : 2500002","Paris","75019",{"lat":395,"lon":396},48.85341,2.3488,{"facility":398,"city":392,"zip":399,"country":372,"geoPoint":400},"Investigational Site Number : 2500003","75571",{"lat":395,"lon":396},{"facility":402,"city":403,"zip":404,"country":405,"geoPoint":406},"Investigational Site Number : 2760002","Düsseldorf","40217","Germany",{"lat":407,"lon":408},51.22319,6.77927,{"facility":410,"city":411,"zip":412,"country":405,"geoPoint":413},"Investigational Site Number : 2760004","Frankfurt","60590",{"lat":414,"lon":415},49.68333,10.53333,{"facility":417,"city":418,"zip":419,"country":405,"geoPoint":420},"Investigational Site Number : 2760001","Leipzig","04103",{"lat":421,"lon":422},51.33962,12.37129,{"facility":424,"city":425,"zip":426,"country":427,"geoPoint":428},"Investigational Site Number : 3000001","Athens","115 27","Greece",{"lat":429,"lon":430},37.98376,23.72784,{"facility":432,"city":425,"zip":433,"country":427,"geoPoint":434},"Investigational Site Number : 3000003","152 36",{"lat":429,"lon":430},{"facility":436,"city":437,"zip":438,"country":439,"geoPoint":440},"Investigational Site Number : 3480005","Budapest","1085","Hungary",{"lat":441,"lon":442},47.49835,19.04045,{"facility":444,"city":445,"zip":446,"country":439,"geoPoint":447},"Investigational Site Number : 3480004","Debrecen","4032",{"lat":448,"lon":449},47.53167,21.62444,{"facility":451,"city":452,"zip":453,"country":439,"geoPoint":454},"Investigational Site Number : 3480002","Székesfehérvár","8000",{"lat":455,"lon":456},47.18995,18.41034,{"facility":458,"city":459,"zip":460,"country":439,"geoPoint":461},"Investigational Site Number : 3480001","Szigetvár","7900",{"lat":462,"lon":463},46.04865,17.80554,{"facility":465,"city":466,"state":467,"zip":468,"country":469,"geoPoint":470},"Buzzi Children's Hospital - Investigational Site Number : 3800003","Milan","Lombardy","20154","Italy",{"lat":471,"lon":472},45.46427,9.18951,{"facility":474,"city":475,"state":476,"zip":477,"country":469,"geoPoint":478},"Investigational Site Number : 3800005","Padua","Padova","35128",{"lat":479,"lon":480},45.40797,11.88586,{"facility":482,"city":483,"state":484,"zip":485,"country":469,"geoPoint":486},"Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002","Rome","Roma","00165",{"lat":487,"lon":488},41.89193,12.51133,{"facility":490,"city":491,"zip":492,"country":469,"geoPoint":493},"AOU Luigi Vanvitelli - Investigational Site Number : 3800004","Naples","80131",{"lat":494,"lon":495},40.85216,14.26811,{"facility":497,"city":498,"zip":499,"country":469,"geoPoint":500},"Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001","Pavia","27100",{"lat":501,"lon":502},45.19205,9.15917,{"facility":504,"city":505,"state":506,"zip":507,"country":508,"geoPoint":509},"Investigational Site Number : 3920006","Isehara","Kanagawa","259-1193","Japan",{"lat":510,"lon":511},35.39932,139.31019,{"facility":513,"city":514,"state":515,"zip":516,"country":508,"geoPoint":517},"Investigational Site Number : 3920004","Tsu","Mie-ken","514-0125",{"lat":518,"lon":519},34.73333,136.51667,{"facility":521,"city":522,"state":523,"zip":524,"country":508,"geoPoint":525},"Investigational Site Number : 3920003","Ureshino","Saga-ken","843-0393",{"lat":526,"lon":527},33.13525,130.05718,{"facility":529,"city":530,"zip":531,"country":508,"geoPoint":532},"Investigational Site Number : 3920002","Fukuoka","811-1394",{"lat":533,"lon":534},33.6,130.41667,{"facility":536,"city":530,"zip":537,"country":508,"geoPoint":538},"Investigational Site Number : 3920001","813-0017",{"lat":533,"lon":534},{"facility":540,"city":541,"state":542,"zip":543,"country":544,"geoPoint":545},"Investigational Site Number : 4840001","San Juan del Río","Querétaro","76800","Mexico",{"lat":546,"lon":547},20.38897,-99.99637,{"facility":549,"city":550,"zip":551,"country":544,"geoPoint":552},"Investigational Site Number : 4840004","Durango","34000",{"lat":553,"lon":554},24.02032,-104.65756,{"facility":556,"city":557,"zip":558,"country":544,"geoPoint":559},"Investigational Site Number : 4840002","Veracruz","91900",{"lat":560,"lon":561},19.18095,-96.1429,{"facility":563,"city":564,"zip":565,"country":566,"geoPoint":567},"Investigational Site Number : 5280001","Rotterdam","3015 CE","Netherlands",{"lat":568,"lon":569},51.9225,4.47917,{"facility":571,"city":572,"state":573,"zip":574,"country":575,"geoPoint":576},"Investigational Site Number : 6160004","Tarnów","Lesser Poland Voivodeship","33-100","Poland",{"lat":577,"lon":578},50.01381,20.98698,{"facility":580,"city":581,"state":582,"zip":583,"country":575,"geoPoint":584},"Investigational Site Number : 6160001","Lodz","Lódzkie","93-509",{"lat":585,"lon":586},51.77058,19.47395,{"facility":588,"city":589,"state":590,"zip":591,"country":575,"geoPoint":592},"Investigational Site Number : 6160003","Warsaw","Masovian Voivodeship","02-091",{"lat":593,"lon":594},52.22977,21.01178,{"facility":596,"city":597,"state":598,"zip":599,"country":600,"geoPoint":601},"Investigational Site Number : 7240003","Santiago de Compostela","A Coruña [La Coruña]","15706","Spain",{"lat":602,"lon":603},42.88052,-8.54569,{"facility":605,"city":606,"state":607,"zip":608,"country":600,"geoPoint":609},"Investigational Site Number : 7240001","Barcelona","Barcelona [Barcelona]","08035",{"lat":610,"lon":611},41.38879,2.15899,{"facility":613,"city":614,"state":607,"zip":615,"country":600,"geoPoint":616},"Investigational Site Number : 7240007","Esplugues de Llobregat","08950",{"lat":617,"lon":618},41.37732,2.08809,{"facility":620,"city":621,"state":607,"zip":622,"country":600,"geoPoint":623},"Investigational Site Number : 7240002","Sabadell","08208",{"lat":624,"lon":625},41.54329,2.10942,{"facility":627,"city":628,"state":629,"zip":630,"country":600,"geoPoint":631},"Investigational Site Number : 7240006","Jerez de la Frontera","Cádiz","11407",{"lat":632,"lon":633},36.68645,-6.13606,{"facility":635,"city":636,"zip":637,"country":600,"geoPoint":638},"Investigational Site Number : 7240005","Madrid","28009",{"lat":639,"lon":640},40.4165,-3.70256,{"facility":642,"city":643,"zip":644,"country":600,"geoPoint":645},"Investigational Site Number : 7240004","Valencia","46026",{"lat":646,"lon":647},39.47391,-0.37966,{"facility":649,"city":650,"state":651,"zip":652,"country":653,"geoPoint":654},"Investigational Site Number : 8260003","Birmingham","England","B4 6NH","United Kingdom",{"lat":655,"lon":656},52.48142,-1.89983,{"facility":658,"city":659,"state":660,"zip":661,"country":653,"geoPoint":662},"Investigational Site Number : 8260002","Leicester","Leicestershire","LE1 5WW",{"lat":663,"lon":664},52.6386,-1.13169,{"facility":666,"city":667,"state":668,"zip":669,"country":653,"geoPoint":670},"Investigational Site Number : 8260001","London","London, City of","SE5 9RL",{"lat":671,"lon":672},51.50853,-0.12574,{"facility":674,"city":675,"zip":676,"country":653,"geoPoint":677},"Investigational Site Number : 8260004","Bradford","BD9 6RJ",{"lat":678,"lon":679},53.79391,-1.75206,[],[],[],[],{"nct_id":4,"conditions":685,"biomarkers":686},[20,19],[687,688],"Eosinophilia","IgE",{"nct_id":4,"found":690,"summary":691,"prompt_version":701},true,{"design":692,"status":693,"heading":694,"summary":695,"follow_up":696,"word_count":697,"commitments":698,"compensation":699,"drugs_mentioned":700},"This is a Phase 3 study with two parts. Part A is a 52-week, randomized, double-blind (meaning neither you nor the doctors will know if your child is getting Dupilumab or placebo) study, followed by an optional open-label extension in Part B. About 90 participants are planned.","completed","Dupilumab for Asthma\u002FAsthmatic Wheeze in Young Children","This study is looking at Dupilumab, an injection given under the skin, to see if it can help children aged 2 to under 6 years old who have uncontrolled asthma or frequent severe wheezing. Researchers want to find out if Dupilumab is safe and effective in reducing severe asthma attacks. You could be eligible if your child has asthma or recurrent severe wheezing that isn't well-controlled with their current inhaled steroid medicine. The study will compare Dupilumab to a placebo (an inactive injection) over 52 weeks. After this initial period, there's an option for participants to continue in an open-label extension phase, where everyone receives Dupilumab. The study aims to enroll about 90 children.","After the 52-week treatment period in Part A, there is a 12-week post-treatment follow-up period. For Part B, safety will be measured up to Week 116.",114,"Your child would participate for up to 120 weeks. Part A involves a 4-week screening, a 52-week treatment period, and a 12-week follow-up after treatment.","Not stated in the trial record.",[32,40],"v2"]