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Frontera","Cádiz","11407",{"type":48,"coordinates":709},[710,711],-6.13606,36.68645,{"lat":711,"lon":710},{"facility":714,"status":42,"city":715,"state":31,"zip":716,"country":669,"cosmosGeoPoint":717,"geoPoint":721,"contacts":31},"Investigational Site Number : 7240005","Madrid","28009",{"type":48,"coordinates":718},[719,720],-3.70256,40.4165,{"lat":720,"lon":719},{"facility":723,"status":42,"city":724,"state":31,"zip":725,"country":669,"cosmosGeoPoint":726,"geoPoint":730,"contacts":31},"Investigational Site Number : 7240004","Valencia","46026",{"type":48,"coordinates":727},[728,729],-0.37966,39.47391,{"lat":729,"lon":728},{"facility":732,"status":42,"city":733,"state":734,"zip":735,"country":736,"cosmosGeoPoint":737,"geoPoint":741,"contacts":31},"Investigational Site Number : 8260003","Birmingham","England","B4 6NH","United Kingdom",{"type":48,"coordinates":738},[739,740],-1.89983,52.48142,{"lat":740,"lon":739},{"facility":743,"status":42,"city":744,"state":745,"zip":746,"country":736,"cosmosGeoPoint":747,"geoPoint":751,"contacts":31},"Investigational Site Number : 8260002","Leicester","Leicestershire","LE1 5WW",{"type":48,"coordinates":748},[749,750],-1.13169,52.6386,{"lat":750,"lon":749},{"facility":753,"status":42,"city":754,"state":755,"zip":756,"country":736,"cosmosGeoPoint":757,"geoPoint":761,"contacts":31},"Investigational Site Number : 8260001","London","London, City of","SE5 9RL",{"type":48,"coordinates":758},[759,760],-0.12574,51.50853,{"lat":760,"lon":759},{"facility":763,"status":42,"city":764,"state":31,"zip":765,"country":736,"cosmosGeoPoint":766,"geoPoint":770,"contacts":31},"Investigational Site Number : 8260004","Bradford","BD9 6RJ",{"type":48,"coordinates":767},[768,769],-1.75206,53.79391,{"lat":769,"lon":768},{"type":772,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[774],{"name":775,"class":6},"Regeneron Pharmaceuticals","100530786",false,"NCT06191315","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","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.","ALL","2 Years","5 Years",{"count":786,"type":787},90,"ESTIMATED","INTERVENTIONAL",[790],"PHASE3","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).",[793,794],"Wheezing","Asthma","2026-03-19",{"date":797,"type":798},"2026-03-20","ACTUAL",{"date":800,"type":798},"2024-01-03",{"date":802,"type":787},"2028-12-21",{"name":5,"class":6},74]