[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05735483":3,"trial-entities:NCT05735483":769,"trial-summary:NCT05735483":772},{"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":41,"secondary_outcomes":45,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":80,"locations":83,"central_contacts":759,"overall_officials":760,"references":764,"see_also_links":765},"NCT05735483","18266","A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to \u003C18 Years of Age With Moderate-to-Severe Atopic Dermatitis","A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to \u003C18 Years of Age With Moderate-to-Severe Atopic Dermatitis","ENROLLING_BY_INVITATION","2029-04","2026-07","2026-07-30","2023-03-09","Eli Lilly and Company","INDUSTRY",true,"The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \\\u003C18 years of age with moderate-to-severe atopic dermatitis.\n\nThis study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.",null,[19,20],"Atopic Dermatitis","Eczema",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},333,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Lebrikizumab","Administered SC",[32,35],"Lebrikizumab - Optional Extension Period (OEP)",[37],"LY3650150",{"type":31,"name":39,"description":33,"armGroupLabels":40},"Placebo",[32,35],[42],{"measure":43,"timeFrame":44},"Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)","Baseline through Week 52",[46,49,51,53,55,58,60,62,64],{"measure":47,"timeFrame":48},"Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ","Baseline to Week 52",{"measure":50,"timeFrame":48},"Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ",{"measure":52,"timeFrame":48},"Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ",{"measure":54,"timeFrame":48},"Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ",{"measure":56,"timeFrame":57},"Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score","Baseline, Week 52",{"measure":59,"timeFrame":57},"Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)",{"measure":61,"timeFrame":57},"Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI",{"measure":63,"timeFrame":57},"Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI",{"measure":65,"timeFrame":57},"Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)","ALL","6 Months","18 Years",false,{"inclusion":71,"exclusion":74,"raw_text":79},[72,73],"Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.","For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies",[75,76,77,78],"Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.","Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.","Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)","Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.","Inclusion Criteria:\n\n* Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.\n* For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n\nExclusion Criteria:\n\n* Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.\n* Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.\n* Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)\n\nNote: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.\n\n* Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.",[81,82],"CHILD","ADULT",[84,93,101,109,117,124,131,139,147,154,162,170,178,186,194,201,209,217,225,233,240,248,253,256,260,263,267,274,282,291,298,306,313,321,329,337,344,351,358,362,369,378,386,395,403,412,420,428,436,445,452,460,468,476,485,493,499,507,515,522,530,538,546,553,561,569,578,586,593,597,601,609,617,621,628,637,645,653,661,670,675,682,686,690,694,701,709,717,725,733,738,745,749,752],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Clinical Research Center of Alabama","Birmingham","Alabama","35209","United 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Hampshire","03766",{"lat":207,"lon":208},43.64229,-72.25176,{"facility":210,"city":211,"state":212,"zip":213,"country":89,"geoPoint":214},"Wright State Physicians","Fairborn","Ohio","45324",{"lat":215,"lon":216},39.82089,-84.01938,{"facility":218,"city":219,"state":220,"zip":221,"country":89,"geoPoint":222},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":223,"lon":224},32.77632,-79.93275,{"facility":226,"city":227,"state":228,"zip":229,"country":89,"geoPoint":230},"The University of Texas Health Science Center at Houston","Bellaire","Texas","77401",{"lat":231,"lon":232},29.70579,-95.45883,{"facility":234,"city":235,"state":228,"zip":236,"country":89,"geoPoint":237},"Texas Dermatology and Laser Specialists","San Antonio","78218",{"lat":238,"lon":239},29.42412,-98.49363,{"facility":241,"city":242,"state":243,"zip":244,"country":89,"geoPoint":245},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"lat":246,"lon":247},43.0389,-87.90647,{"facility":249,"city":250,"state":250,"zip":251,"country":252},"CONEXA Investigacion Clinica S.A.","Buenos Aires","1012","Argentina",{"facility":254,"city":250,"state":250,"zip":255,"country":252},"Fundación Respirar","C1426ABP",{"facility":257,"city":258,"state":250,"zip":259,"country":252},"Instituto de Neumonología Y Dermatología","Ciudad Autonoma de Buenos Aire","1425",{"facility":261,"city":258,"state":250,"zip":262,"country":252},"Psoriahue","C1425DKG",{"facility":264,"city":265,"state":250,"zip":266,"country":252},"Centro de Investigaciones Metabólicas (CINME)","Ciudad Autónoma de Buenos Aires","1027",{"facility":268,"city":250,"state":269,"zip":270,"country":252,"geoPoint":271},"Fundacion Cidea","Buenos Aires F.D.","C1121ABE",{"lat":272,"lon":273},-34.61315,-58.37723,{"facility":275,"city":276,"state":277,"zip":278,"country":252,"geoPoint":279},"Fundacion Estudios Clinicos","Rosario","Santa Fe 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Janeiro","20241-180","Brazil",{"lat":319,"lon":320},-22.90642,-43.18223,{"facility":322,"city":323,"state":324,"zip":325,"country":317,"geoPoint":326},"Hospital de Clinicas de Porto Alegre","Porto Alegre","Rio Grande do Sul","90035-903",{"lat":327,"lon":328},-30.03283,-51.23019,{"facility":330,"city":331,"state":332,"zip":333,"country":317,"geoPoint":334},"Fundação Pio XII - Hospital de Câncer de Barretos","Barretos","São Paulo","14784400",{"lat":335,"lon":336},-20.55722,-48.56778,{"facility":338,"city":339,"state":332,"zip":340,"country":317,"geoPoint":341},"Centro de Pesquisa Sao Lucas","Campinas","13060-803",{"lat":342,"lon":343},-22.90556,-47.06083,{"facility":345,"city":346,"state":332,"zip":347,"country":317,"geoPoint":348},"Hospital de Clínicas de Ribeirão Preto","Ribeirão Preto","14051-140",{"lat":349,"lon":350},-21.1775,-47.81028,{"facility":352,"city":353,"state":332,"zip":354,"country":317,"geoPoint":355},"Faculdade de Medicina do ABC","Santo André","09060-870",{"lat":356,"lon":357},-23.66389,-46.53833,{"facility":359,"city":353,"state":332,"zip":360,"country":317,"geoPoint":361},"Pesquisare Saude","09080-110",{"lat":356,"lon":357},{"facility":363,"city":364,"state":332,"zip":365,"country":317,"geoPoint":366},"Clinica de Alergia Martti Antila","Sorocaba","18040-425",{"lat":367,"lon":368},-23.50167,-47.45806,{"facility":370,"city":371,"state":372,"zip":373,"country":374,"geoPoint":375},"Dermatology Research Institute","Calgary","Alberta","T2J 7E1","Canada",{"lat":376,"lon":377},51.05011,-114.08529,{"facility":379,"city":380,"state":381,"zip":382,"country":374,"geoPoint":383},"DermEdge Research","Mississauga","Ontario","L4Y 4C5",{"lat":384,"lon":385},43.5789,-79.6583,{"facility":387,"city":388,"state":389,"zip":390,"country":391,"geoPoint":392},"Detska nemocnice FN Brno","Brno","Brno-město","613 00","Czechia",{"lat":393,"lon":394},49.19522,16.60796,{"facility":396,"city":397,"state":398,"zip":399,"country":391,"geoPoint":400},"Fakultni nemocnice Bulovka","Prague","Praha 8","180 81",{"lat":401,"lon":402},50.08804,14.42076,{"facility":404,"city":405,"state":406,"zip":407,"country":408,"geoPoint":409},"Hôpitaux Drôme Nord - Romans","Romans-sur-Isère","Drôme","26102","France",{"lat":410,"lon":411},45.0496,5.06602,{"facility":413,"city":414,"state":415,"zip":416,"country":408,"geoPoint":417},"Hôpital Saint Vincent-de-Paul","Lille","Hauts-de-France","59020",{"lat":418,"lon":419},50.63391,3.05512,{"facility":421,"city":422,"state":423,"zip":424,"country":408,"geoPoint":425},"Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu","Nantes","Loire-Atlantique","44093 Cedex 1",{"lat":426,"lon":427},47.21725,-1.55336,{"facility":429,"city":430,"state":431,"zip":432,"country":408,"geoPoint":433},"CHU de Toulouse - Hopital 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City","06090",{"lat":591,"lon":592},19.42847,-99.12766,{"facility":594,"city":588,"state":588,"zip":595,"country":574,"geoPoint":596},"Trials in Medicine","06700",{"lat":591,"lon":592},{"facility":598,"city":588,"state":588,"zip":599,"country":574,"geoPoint":600},"Hospital Infantil de Mexico Federico Gomez","06720",{"lat":591,"lon":592},{"facility":602,"city":603,"state":604,"zip":605,"country":574,"geoPoint":606},"PanAmerican Clinical Research - Cuernavaca","Cuernavaca","Morelos","62290",{"lat":607,"lon":608},18.9261,-99.23075,{"facility":610,"city":611,"state":612,"zip":613,"country":574,"geoPoint":614},"Eukarya PharmaSite","Monterrey","Nuevo León","64718",{"lat":615,"lon":616},25.68435,-100.31721,{"facility":618,"city":611,"state":612,"zip":619,"country":574,"geoPoint":620},"Hospital Universitario \"Dr. Jose Eleuterio Gonzalez\"","66460",{"lat":615,"lon":616},{"facility":622,"city":623,"state":623,"zip":624,"country":574,"geoPoint":625},"Arké SMO S.A de 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