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and age",[13],"Drug: Dupilumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Injection solution Subcutaneous",[9],[20],"Dupixent",null,[23,36,46,56,66,74,84,93,103,113,125,134,144,154,166],{"facility":24,"status":21,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":21},"Pediatric Dermatology of Miami Site Number : 8400015","Coral Gables","Florida","33146","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-80.26838,25.72149,{"lat":34,"lon":33},{"facility":37,"status":21,"city":38,"state":39,"zip":40,"country":28,"countryCode":29,"cosmosGeoPoint":41,"geoPoint":45,"contacts":21},"Treasure Valley Medical Research Site Number : 8400019","Boise","Idaho","83706",{"type":31,"coordinates":42},[43,44],-116.20345,43.6135,{"lat":44,"lon":43},{"facility":47,"status":21,"city":48,"state":49,"zip":50,"country":28,"countryCode":29,"cosmosGeoPoint":51,"geoPoint":55,"contacts":21},"Washington University School of Medicine- Site Number : 8400004","St Louis","Missouri","63110",{"type":31,"coordinates":52},[53,54],-90.19789,38.62727,{"lat":54,"lon":53},{"facility":57,"status":21,"city":58,"state":59,"zip":60,"country":28,"countryCode":29,"cosmosGeoPoint":61,"geoPoint":65,"contacts":21},"Boston Childrens Health Physicians Site Number : 8400017","Hawthorne","New York","10532",{"type":31,"coordinates":62},[63,64],-73.79597,41.10732,{"lat":64,"lon":63},{"facility":67,"status":21,"city":59,"state":59,"zip":68,"country":28,"countryCode":29,"cosmosGeoPoint":69,"geoPoint":73,"contacts":21},"Columbia University Irving Medical Center Site Number : 8400003","10032",{"type":31,"coordinates":70},[71,72],-74.00597,40.71427,{"lat":72,"lon":71},{"facility":75,"status":21,"city":76,"state":77,"zip":78,"country":28,"countryCode":29,"cosmosGeoPoint":79,"geoPoint":83,"contacts":21},"Childrens Hospital Medical Center of Akron- Site Number : 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8400005","Nashville","Tennessee","37232",{"type":31,"coordinates":109},[110,111],-86.78444,36.16589,{"lat":111,"lon":110},{"facility":114,"status":21,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":21},"Investigational Site Number : 1240009","Calgary","Alberta","T2W 4X9","Canada","CA",{"type":31,"coordinates":121},[122,123],-114.08529,51.05011,{"lat":123,"lon":122},{"facility":126,"status":21,"city":127,"state":116,"zip":128,"country":118,"countryCode":119,"cosmosGeoPoint":129,"geoPoint":133,"contacts":21},"Investigational Site Number : 1240010","Edmonton","T5J 3S9",{"type":31,"coordinates":130},[131,132],-113.46871,53.55014,{"lat":132,"lon":131},{"facility":135,"status":21,"city":136,"state":137,"zip":138,"country":118,"countryCode":119,"cosmosGeoPoint":139,"geoPoint":143,"contacts":21},"Investigational Site Number : 1240007","Hamilton","Ontario","L8S1G5",{"type":31,"coordinates":140},[141,142],-79.84963,43.25011,{"lat":142,"lon":141},{"facility":145,"status":21,"city":146,"state":147,"zip":148,"country":118,"countryCode":119,"cosmosGeoPoint":149,"geoPoint":153,"contacts":21},"Investigational Site Number : 1240001","Montreal","Quebec","H4A 3J1",{"type":31,"coordinates":150},[151,152],-73.58781,45.50884,{"lat":152,"lon":151},{"facility":155,"status":21,"city":156,"state":157,"zip":158,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":21},"Investigational Site Number : 3920001","Yokohama","Kanagawa","232-8555","Japan","JP",{"type":31,"coordinates":162},[163,164],139.65,35.43333,{"lat":164,"lon":163},{"facility":167,"status":21,"city":168,"state":169,"zip":170,"country":159,"countryCode":160,"cosmosGeoPoint":171,"geoPoint":175,"contacts":21},"Investigational Site Number : 3920002","Tsu","Mie-ken","514-0125",{"type":31,"coordinates":172},[173,174],136.51667,34.73333,{"lat":174,"lon":173},{"type":177,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100479710","phase-3-a-study-to-investigate-the-pharmacokinetics-and-safety-of-dupilumab-in-participants-2-years-to-12-years-of-age-with-uncontrolled-chronic-spontaneous-urticaria-csu-liberty-csu-cupidkids-100479710",true,"NCT05526521","A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to \u003C12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)","A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to \u003C12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)","Inclusion Criteria:\n\n* Participant must be ≥ 2 years to \\\u003C12 years of age, at the time of signing the informed consent.\n* Participants who had history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion.\n* Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for \\>6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.\n* Body weight within ≥5 kg to \\\u003C60 kg.\n* Participant\u002Fparent(s)\u002Fcaregiver(s)\u002Fparticipant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.\n\nExclusion Criteria:\n\nParticipants were excluded from the study if any of the following criteria apply:\n\n* Underlying etiology for chronic urticarias other than CSU.\n* Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.\n* Participants with a diagnosis of chronic inducible cold urticaria.\n* Participants with active AD.\n* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.\n* Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated.\n* Diagnosed with, suspected of, or at high risk of endoparasitic infection.\n* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.\n* Known or suspected immunodeficiency.\n* Active malignancy or history of malignancy within 5 years before the baseline visit.\n* History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.\n* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",false,"ALL","2 Years","11 Years",{"count":190,"type":191},15,"ACTUAL","INTERVENTIONAL",[194],"PHASE3","This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.",[197],"Chronic Spontaneous Urticaria","COMPLETED","2025-11-19",{"date":201,"type":191},"2025-11-25",{"date":203,"type":191},"2022-08-25",{"date":205,"type":191},"2025-02-03",{"name":5,"class":6}]