[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467872":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":368,"collaborators":35,"id":370,"slug":371,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":378,"sex":379,"minAge":380,"maxAge":35,"enrollmentInfo":381,"targetDuration":35,"studyType":384,"phases":385,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":392,"whyStopped":35,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Lebrikizumab 250 mg Q2W","EXPERIMENTAL","Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.",[13],"Drug: Lebrikizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W","Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W","Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Lebrikizumab","Administered SC",[9,15,19],[29,30],"LY3650150","DRM06",[32],{"name":33,"affiliation":5,"role":34},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",null,[37,50,60,69,78,87,96,102,111,120,129,137,147,157,166,175,184,193,202,212,221,231,241,251,260,270,280,289,299,309,319,328,337,343,349,358],{"facility":38,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":35},"Total Skin and Beauty Dermatology Center, PC","Birmingham","Alabama","35205","United 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Beach","Florida","33436",{"type":45,"coordinates":153},[154,155],-80.06643,26.52535,{"lat":155,"lon":154},{"facility":158,"status":35,"city":159,"state":150,"zip":160,"country":42,"countryCode":43,"cosmosGeoPoint":161,"geoPoint":165,"contacts":35},"Skin Care Research, Inc","Hollywood","33021",{"type":45,"coordinates":162},[163,164],-80.14949,26.0112,{"lat":164,"lon":163},{"facility":167,"status":35,"city":168,"state":150,"zip":169,"country":42,"countryCode":43,"cosmosGeoPoint":170,"geoPoint":174,"contacts":35},"Solutions Through Advanced Research","Jacksonville","32256",{"type":45,"coordinates":171},[172,173],-81.65565,30.33218,{"lat":173,"lon":172},{"facility":176,"status":35,"city":177,"state":150,"zip":178,"country":42,"countryCode":43,"cosmosGeoPoint":179,"geoPoint":183,"contacts":35},"Miami Dermatology and Laser 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Louis","Missouri","63110",{"type":45,"coordinates":266},[267,268],-90.19789,38.62727,{"lat":268,"lon":267},{"facility":271,"status":35,"city":272,"state":273,"zip":274,"country":42,"countryCode":43,"cosmosGeoPoint":275,"geoPoint":279,"contacts":35},"Skin Specialists, P.C","Omaha","Nebraska","68144",{"type":45,"coordinates":276},[277,278],-95.94043,41.25626,{"lat":278,"lon":277},{"facility":281,"status":35,"city":282,"state":282,"zip":283,"country":42,"countryCode":43,"cosmosGeoPoint":284,"geoPoint":288,"contacts":35},"Sadick Research Group","New York","10075",{"type":45,"coordinates":285},[286,287],-74.00597,40.71427,{"lat":287,"lon":286},{"facility":290,"status":35,"city":291,"state":292,"zip":293,"country":42,"countryCode":43,"cosmosGeoPoint":294,"geoPoint":298,"contacts":35},"Wilmington Health Family Medicine","Wilmington","North Carolina","28411",{"type":45,"coordinates":295},[296,297],-77.94604,34.23556,{"lat":297,"lon":296},{"facility":300,"status":35,"city":301,"state":302,"zip":303,"country":42,"countryCode":43,"cosmosGeoPoint":304,"geoPoint":308,"contacts":35},"Dermatology & Laser Center of Charleston","Charleston","South Carolina","29407",{"type":45,"coordinates":305},[306,307],-79.93275,32.77632,{"lat":307,"lon":306},{"facility":310,"status":35,"city":311,"state":312,"zip":313,"country":42,"countryCode":43,"cosmosGeoPoint":314,"geoPoint":318,"contacts":35},"Arlington Research Center, Inc","Arlington","Texas","76011",{"type":45,"coordinates":315},[316,317],-97.10807,32.73569,{"lat":317,"lon":316},{"facility":320,"status":35,"city":321,"state":312,"zip":322,"country":42,"countryCode":43,"cosmosGeoPoint":323,"geoPoint":327,"contacts":35},"Clinical Trial Network","Houston","77074",{"type":45,"coordinates":324},[325,326],-95.36327,29.76328,{"lat":326,"lon":325},{"facility":329,"status":35,"city":330,"state":312,"zip":331,"country":42,"countryCode":43,"cosmosGeoPoint":332,"geoPoint":336,"contacts":35},"Progressive Clinical Research","San Antonio","78213",{"type":45,"coordinates":333},[334,335],-98.49363,29.42412,{"lat":335,"lon":334},{"facility":338,"status":35,"city":330,"state":312,"zip":339,"country":42,"countryCode":43,"cosmosGeoPoint":340,"geoPoint":342,"contacts":35},"Texas Dermatology and Laser Specialists","78218",{"type":45,"coordinates":341},[334,335],{"lat":335,"lon":334},{"facility":344,"status":35,"city":330,"state":312,"zip":345,"country":42,"countryCode":43,"cosmosGeoPoint":346,"geoPoint":348,"contacts":35},"Dermatology Clinical Research Center of San Antonio","78229",{"type":45,"coordinates":347},[334,335],{"lat":335,"lon":334},{"facility":350,"status":35,"city":351,"state":312,"zip":352,"country":42,"countryCode":43,"cosmosGeoPoint":353,"geoPoint":357,"contacts":35},"Complete Dermatology","Sugar Land","77479",{"type":45,"coordinates":354},[355,356],-95.63495,29.61968,{"lat":356,"lon":355},{"facility":359,"status":35,"city":360,"state":361,"zip":362,"country":42,"countryCode":43,"cosmosGeoPoint":363,"geoPoint":367,"contacts":35},"Virginia Clinical Research, Inc.","Norfolk","Virginia","23502",{"type":45,"coordinates":364},[365,366],-76.28522,36.84681,{"lat":366,"lon":365},{"type":369,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100467872","phase-3-a-study-of-ly3650150-lebrikizumab-to-assess-the-safety-and-efficacy-of-adult-and-adolescent-participants-with-moderate-to-severe-atopic-dermatitis-and-skin-of-color-100467872",true,"NCT05372419","A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color","An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color","ADmirable","Inclusion Criteria:\n\nParticipants must be ≥12 years of age inclusive, at the time of signing the informed consent\u002Fassent.\n\n* Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.\n* Participants who are Fitzpatrick phototype IV-VI\n* Participants who have chronic AD that has been present for ≥1 year before screening.\n* Have EASI ≥16 at baseline\n* Have IGA score ≥3 (Scale of 0 to 4) at baseline\n* Have ≥10% body surface area (BSA) of AD involvement at baseline\n* Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.\n* Adolescents body weight must be ≥40 kg at baseline.\n* Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.\n* Contraceptive use - Male and\u002For female\n\n  * Male participants are not required to use any contraception except in compliance with specific local government study requirements.\n  * Female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. Women of non-child-bearing potential (non-WOCBP) may participate without any contraception requirements.\n\nExclusion Criteria:\n\n* History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.\n* Have a current infection or chronic infection with hepatitis B virus (HBV) at screening, that is, positive for hepatitis B surface antigen (HBsAg) and\u002For polymerase chain reaction positive for HBV DNA\n* Have a current infection with hepatitis C virus (HCV) at screening, that is, positive for HCV RNA\n* Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).\n* Have uncontrolled asthma that\n\n  * might require bursts of oral or systemic corticosteroids, or\n  * required the following due to ≥1 exacerbations within 12 months before baseline\n\n    * systemic (oral and\u002For parenteral) corticosteroid treatment, or\n    * hospitalization for \\>24 hours.\n* Have known liver cirrhosis and\u002For chronic hepatitis of any etiology.\n* Had prior treatment with dupilumab\n* Had prior treatment with tralokinumab\n* Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.\n* Treatment with any of the following agents within 4 weeks prior to the baseline:\n\n  * systemic immunosuppressive\u002Fimmunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants);\n  * small molecules (for example, Janus Kinase (JAK) inhibitors);\n  * phototherapy and photochemotherapy for AD.\n* History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.",false,"ALL","12 Years",{"count":382,"type":383},90,"ACTUAL","INTERVENTIONAL",[386],"PHASE3","The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.",[389],"Atopic Dermatitis",[391],"Eczema","COMPLETED","2026-02-16",{"date":395,"type":383},"2026-03-09",{"date":397,"type":383},"2023-01-12",{"date":399,"type":383},"2025-02-17",{"name":5,"class":6},36]