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NCT05735483Enrolling by invitationPhase 3

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 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 <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This 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.

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
338 (estimated)
First submitted
10 Feb 2023
Start date
9 Mar 2023
Primary completion date
31 Dec 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT05735483
EU CT number
2022-501478-21-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 338
  • From 9 Mar 2023 to the primary completion date, 31 Dec 2027
  • 93 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.)
    • Note: 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.

Other

  • Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.

Who the study is looking for

  • 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

Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (93)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundacion Cidea
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Buenos AiresArgentinaUnknown status
CONEXA Investigacion Clinica S.A.
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Buenos AiresArgentinaUnknown status
Fundacion Respirar
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Buenos AiresArgentinaUnknown status
Psoriahue
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
Instituto de Neumonología Y Dermatología
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
Centro de Investigaciones Metabólicas (CINME)
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Fundacion Estudios Clinicos
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RosarioArgentinaUnknown status
Cornerstone Dermatology
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CoorparooAustraliaUnknown status
Sydney Children's Hospital
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RandwickAustraliaUnknown status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
Veracity Clinical Research Pty Ltd
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WoolloongabbaAustraliaUnknown status
Fundação Pio XII - Hospital de Câncer de Barretos
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BarretosBrazilUnknown status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital de Clínicas de Ribeirão Preto
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Ribeirão PretoBrazilUnknown status
IBPClin - Instituto Brasil de Pesquisa Clínica
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Rio de JaneiroBrazilUnknown status
Faculdade de Medicina do ABC
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Santo AndréBrazilUnknown status
Pesquisare Saude
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Santo AndréBrazilUnknown status
Clinica de Alergia Martti Antila
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SorocabaBrazilUnknown status
Dermatology Research Institute
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CalgaryCanadaUnknown status
DermEdge Research
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MississaugaCanadaUnknown status
Fakultni Nemocnice Brno
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Brno-SeverCzechiaActive, not recruiting
Fakultni nemocnice Bulovka
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PragueCzechiaActive, not recruiting
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyActive, not recruiting
Rosenpark Research Gmbh
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DarmstadtGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MünsterGermanyActive, not recruiting
Hospital Sant Joan de Déu
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BarcelonaSpainActive, not recruiting
Hospital Universitario de Gran Canaria Dr Negrín
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Las Palmas de Gran CanariaSpainActive, not recruiting
Grupo Dermatológico y Estético Pedro Jaén S.A
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MadridSpainActive, not recruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital de Manises
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ManisesSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Hopitaux Drome Nord
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Romans-Sur-IsereFranceNot yet recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceNot yet recruiting
Asahikawa Medical College Hospital
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AsahikawaJapanUnknown status
Fukuyama City Hospital
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FukuyamaJapanUnknown status
Osaka Habikino Medical Center
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HabikinoJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Ina Central Hospital
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InaJapanUnknown status
Enomoto Clinic
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KumagayaJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Okayama City General Medical Center Okayama City Hospital
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OkayamaJapanUnknown status
National Hospital Organization Sagamihara National Hospital
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SagamiharaJapanUnknown status
Dermatology and Ophthalmology Kume Clinic
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SakaiJapanUnknown status
Sugamo Sengoku Dermatology
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Toshima CityJapanUnknown status
Fujita Health University
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ToyoakeJapanUnknown status
Scientia Investigacion Clinica S.C.
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Chihuahua CityMexicoUnknown status
PanAmerican Clinical Research - Cuernavaca
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CuernavacaMexicoUnknown status
Trials in Medicine
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Mexico CityMexicoUnknown status
Hospital Infantil de Mexico Federico Gomez
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Mexico CityMexicoUnknown status
Hospital de Jesús Nazareno
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Mexico CityMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Eukarya PharmaSite
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MonterreyMexicoUnknown status
Arké SMO S.A de C.V
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VeracruzMexicoUnknown status
Instituto Dermatologico de Jalisco
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ZapopanMexicoUnknown status
Diamond Clinic Sp. z o.o.
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CracowPolandActive, not recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandActive, not recruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandActive, not recruiting
Evimed Sp. z o.o.
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WarsawPolandActive, not recruiting
National Taiwan University Hospital - Hsinchu branch
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HsinchuTaiwanUnknown status
Chang Gung Memorial Hospital at Kaohsiung
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Kaohsiung Niao Sung DistTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
Great Lakes Research Group, Inc.
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Bay CityUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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BellaireUnited StatesUnknown status
Clinical Research Center of Alabama
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BirminghamUnited StatesUnknown status
Treasure Valley Medical Research
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BoiseUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Wright State Physicians
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FairbornUnited StatesUnknown status
UConn Health
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FarmingtonUnited StatesUnknown status
First OC Dermatology
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Fountain ValleyUnited StatesUnknown status
Solutions Through Advanced Research
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JacksonvilleUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
Dermatology Research Associates
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Los AngelesUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Arkansas Research Trials
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North Little RockUnited StatesUnknown status
Allergy and Asthma Specialist
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OwensboroUnited StatesUnknown status
Phoenix Children s Hospital
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PhoenixUnited StatesUnknown status
Integrative Skin Science and Research - Location 2
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SacramentoUnited StatesUnknown status
Texas Dermatology and Laser Specialists
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San AntonioUnited StatesUnknown status
ForCare Clinical Research
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TampaUnited StatesUnknown status
Respiratory Medicine Research Institute of Michigan, PLC
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.