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
NCT ID: NCT05735483
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
310 participants
INTERVENTIONAL
2023-03-09
2029-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lebrikizumab
Participants will receive Lebrikizumab administered subcutaneously (SC).
Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
Lebrikizumab
Administered SC
Placebo
Administered SC
Lebrikizumab - Optional Extension Period (OEP)
During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
Lebrikizumab
Administered SC
Interventions
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Lebrikizumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.)
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.
* Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
6 Months
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research - Location 2
Sacramento, California, United States
UConn Health
Farmington, Connecticut, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Allergy and Asthma Specialist
Owensboro, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Wright State Physicians
Fairborn, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Psoriahue
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundacion Cidea
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
CONEXA Investigacion Clinica S.A.
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
Sydney Children's Hospital
Randwick, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Cornerstone Dermatology
Coorparoo, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Pesquisare Saude
Santo André, São Paulo, Brazil
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
Dermatology Research Institute
Calgary, Alberta, Canada
DermEdge Research
Mississauga, Ontario, Canada
Detska nemocnice FN Brno
Brno, Brno-město, Czechia
Fakultni nemocnice Bulovka
Prague, Praha 8, Czechia
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, Drôme, France
Hôpital Saint Vincent-de-Paul
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, France
Rosenpark Research GmbH
Darmstadt, Hesse, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Niedersach, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Fujita Health University
Toyoake, Aichi-ken, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
Ina Central Hospital
Ina, Nagano, Japan
Osaka Habikino Medical Center
Habikino, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Enomoto Clinic
Kumagaya, Saitama, Japan
Sugamo Sengoku Dermatology
Toshima City, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, , Japan
Instituto Dermatologico de Jalisco
Zapopan, Jalisco, Mexico
Hospital de Jesús Nazareno
Mexico City, Mexico City, Mexico
Trials in Medicine
Mexico City, Mexico City, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, Mexico
PanAmerican Clinical Research - Cuernavaca
Cuernavaca, Morelos, Mexico
Eukarya PharmaSite
Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
Diamond Clinic
Krakow, Małopolski, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
DERMED Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, Poland
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las, Las Palmas, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Pontevedra [Pontevedra], Spain
Hospital de Manises
Manises, València, Spain
Grupo Pedro Jaén
Madrid, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taichung, Taiwan
National Taiwan University Hospital - Hsinchu branch
Hsinchu, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Related Links
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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 (ADorable-2)
Other Identifiers
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J2T-MC-KGBJ/DRM06-AD16
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501478-21-00
Identifier Type: OTHER
Identifier Source: secondary_id
18266
Identifier Type: -
Identifier Source: org_study_id