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Llobregat","08950",{"type":49,"coordinates":704},[705,706],2.08809,41.37732,{"lat":706,"lon":705},{"facility":709,"status":42,"city":710,"state":692,"zip":711,"country":682,"countryCode":683,"cosmosGeoPoint":712,"geoPoint":716,"contacts":31},"Investigational Site Number : 7240002","Sabadell","08208",{"type":49,"coordinates":713},[714,715],2.10942,41.54329,{"lat":715,"lon":714},{"facility":718,"status":42,"city":719,"state":720,"zip":721,"country":682,"countryCode":683,"cosmosGeoPoint":722,"geoPoint":726,"contacts":31},"Investigational Site Number : 7240006","Jerez de la Frontera","Cádiz","11407",{"type":49,"coordinates":723},[724,725],-6.13606,36.68645,{"lat":725,"lon":724},{"facility":728,"status":42,"city":729,"state":31,"zip":730,"country":682,"countryCode":683,"cosmosGeoPoint":731,"geoPoint":735,"contacts":31},"Investigational Site Number : 7240005","Madrid","28009",{"type":49,"coordinates":732},[733,734],-3.70256,40.4165,{"lat":734,"lon":733},{"facility":737,"status":42,"city":738,"state":31,"zip":739,"country":682,"countryCode":683,"cosmosGeoPoint":740,"geoPoint":744,"contacts":31},"Investigational Site Number : 7240004","Valencia","46026",{"type":49,"coordinates":741},[742,743],-0.37966,39.47391,{"lat":743,"lon":742},{"facility":746,"status":42,"city":747,"state":748,"zip":749,"country":750,"countryCode":751,"cosmosGeoPoint":752,"geoPoint":756,"contacts":31},"Investigational Site Number : 8260003","Birmingham","England","B4 6NH","United Kingdom","UK",{"type":49,"coordinates":753},[754,755],-1.89983,52.48142,{"lat":755,"lon":754},{"facility":758,"status":42,"city":759,"state":760,"zip":761,"country":750,"countryCode":751,"cosmosGeoPoint":762,"geoPoint":766,"contacts":31},"Investigational Site Number : 8260002","Leicester","Leicestershire","LE1 5WW",{"type":49,"coordinates":763},[764,765],-1.13169,52.6386,{"lat":765,"lon":764},{"facility":768,"status":42,"city":769,"state":770,"zip":771,"country":750,"countryCode":751,"cosmosGeoPoint":772,"geoPoint":776,"contacts":31},"Investigational Site Number : 8260001","London","London, City of","SE5 9RL",{"type":49,"coordinates":773},[774,775],-0.12574,51.50853,{"lat":775,"lon":774},{"facility":778,"status":42,"city":779,"state":31,"zip":780,"country":750,"countryCode":751,"cosmosGeoPoint":781,"geoPoint":785,"contacts":31},"Investigational Site Number : 8260004","Bradford","BD9 6RJ",{"type":49,"coordinates":782},[783,784],-1.75206,53.79391,{"lat":784,"lon":783},{"type":787,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[789],{"name":790,"class":6},"Regeneron Pharmaceuticals","100530786","phase-3-efficacy-and-safety-of-subcutaneous-dupilumab-in-participants-with-asthmaasthmatic-wheeze-aged-2-to-6-years-liberty-asthma-trekids-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":802,"type":803},90,"ESTIMATED","INTERVENTIONAL",[806],"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).",[809,810],"Wheezing","Asthma","2026-03-19",{"date":813,"type":814},"2026-03-20","ACTUAL",{"date":816,"type":814},"2024-01-03",{"date":818,"type":803},"2028-12-21",{"name":5,"class":6},74]