A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT05559359
Last Updated: 2026-01-21
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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ACTIVE_NOT_RECRUITING
PHASE3
367 participants
INTERVENTIONAL
2022-10-18
2026-12-31
Brief Summary
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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
NCT05735483
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lebrikizumab (Cohort 1)
Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).
Dosing will be based on weight.
Lebrikizumab
Administered SC
Topical Corticosteroid (TCS)
TCS administered
Lebrikizumab (Cohort 2)
Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.
Dosing will be based on weight.
Lebrikizumab
Administered SC
Topical Corticosteroid (TCS)
TCS administered
Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Placebo
Placebo given SC
Topical Corticosteroid (TCS)
TCS administered
Interventions
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Lebrikizumab
Administered SC
Placebo
Placebo given SC
Topical Corticosteroid (TCS)
TCS administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 12 months if participants are ≥6 years of age
* 6 months if participants are 2 to \<6 years of age
* 3 months if participants are 6 months to \<2 years of age.
* Have an EASI score ≥16 at the screening and baseline
* Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
* Have ≥10% BSA of AD involvement at the screening and baseline.
Exclusion Criteria
* Treatment with the following prior to the baseline:
* An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
* Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%.
* Treatment with a topical investigational drug within 2 weeks prior to the baseline.
* Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
6 Months
17 Years
ALL
No
Sponsors
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Dermira, Inc.
INDUSTRY
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
Antelope Valley Clinical Trials
Lancaster, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Rady's Children Hospital San Diego - Dermatology
San Diego, 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 & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Dermatologists of Central States, LLC
Fairborn, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CONEXA Investigacion Clinica S.A.
Buenos Aires, , Argentina
Instituto de Neumonología Y Dermatología
Buenos Aires, , Argentina
Derma Internacional
Buenos Aires, , Argentina
Psoriahue
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
Fundacion Estudios Clinicos
Rosario, , Argentina
Cornerstone Dermatology
Coorparoo, , Australia
Sydney Children's Hospital
Randwick, , Australia
The Children's Hospital at Westmead
Westmead, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, , Brazil
Centro de Pesquisa Sao Lucas
Campinas, , Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, , Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
Clinica de Alergia Martti Antila
Sorocaba, , Brazil
Dermatology Research Institute
Calgary, , Canada
DermEdge Research
Mississauga, , Canada
Fakultni nemocnice Bulovka
Prague, , Czechia
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Rosenpark Research GmbH
Darmstadt, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Münster
Münster, , Germany
Asahikawa Medical University Hospital
Asahikawa, , Japan
Fukuyama City Hospital
Fukuyama, , Japan
Osaka Habikino Medical Center
Habikino, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Ina Central Hospital
Ina, , Japan
Enomoto Clinic
Kumagaya, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, , Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, , Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, , Japan
Sugamo Sengoku Dermatology
Toshima City, , Japan
Fujita Health University
Toyoake, , Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
PanAmerican Clinical Research - Cuernavaca
Cuernavaca, , Mexico
Hospital de Jesús Nazareno
Mexico City, , Mexico
Trials in Medicine
Mexico City, , Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, , Mexico
Eukarya PharmaSite
Monterrey, , Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, , Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
Instituto Dermatologico de Jalisco
Zapopan, , Mexico
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, , Poland
Diamond Clinic
Krakow, , Poland
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, , Poland
Centrum Medyczne Evimed
Warsaw, , Poland
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las, , 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
Clinica Universidad de Navarra
Pamplona, , Spain
National Taiwan University Hospital - Hsinchu branch
Hsinchu, , Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital-Taipei
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 of Lebrikizumab (LY3650150) in Participants 6 Months to \<18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Other Identifiers
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J2T-MC-KGBI
Identifier Type: OTHER
Identifier Source: secondary_id
DRM06-AD13
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005232-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-501476-25-00
Identifier Type: OTHER
Identifier Source: secondary_id
18265
Identifier Type: -
Identifier Source: org_study_id
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