A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Last updated: April 16, 2024
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Skin Infections/disorders

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Treatment

Topical corticosteroid

Lebrikizumab

Placebo

Clinical Study ID

NCT05559359
18265
J2T-MC-KGBI
2021-005232-29
2022-501476-25-00
DRM06-AD13
  • Ages 6-17
  • All Genders

Study Summary

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least:
  • 12 months s if participants are ≥6 years of age, and
  • 6 months if participants are 6 months to <6 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

Exclusion Criteria:

  • Are currently enrolled or have participated within the last 8 weeks in a clinicalstudy involving an investigational intervention or any other type of medical researchjudged not to be scientifically or medically compatible with this study.
  • 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 ofDupilumab 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 4weeks before randomization.

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Topical corticosteroid
Phase: 3
Study Start date:
October 18, 2022
Estimated Completion Date:
June 15, 2025

Connect with a study center

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Air 1027
    Argentina

    Site Not Available

  • Instituto de Neumonología Y Dermatología

    Ciudad Autonoma de Buenos Aire, Buenos Aires 1425
    Argentina

    Active - Recruiting

  • Psoriahue

    Ciudad Autonoma de Buenos Aire, Buenos Aires C1425DKG
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1027
    Argentina

    Site Not Available

  • Fundacion Cidea

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1121ABE
    Argentina

    Active - Recruiting

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe S2000DEJ
    Argentina

    Active - Recruiting

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012
    Argentina

    Active - Recruiting

  • Fundación Respirar

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Sydney Children's Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Cornerstone Dermatology

    Coorparoo, Queensland 4151
    Australia

    Active - Recruiting

  • Veracity Clinical Research

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Active - Recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo 14784400
    Brazil

    Active - Recruiting

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13060-803
    Brazil

    Active - Recruiting

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Site Not Available

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Active - Recruiting

  • Faculdade de Medicina do ABC

    Santo Andre, São Paulo 09060-870
    Brazil

    Active - Recruiting

  • Pesquisare Saude

    Santo André, São Paulo 09080-110
    Brazil

    Active - Recruiting

  • Clinica de Alergia Martti Antila

    Sorocaba, São Paulo 18040-425
    Brazil

    Active - Recruiting

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180
    Brazil

    Active - Recruiting

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • Alberta Dermasurgery Centre

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • DermEdge Research

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Detska nemocnice FN Brno

    Brno, Brno-město 613 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • PreventaMed

    Olomouc, Olomoucký Kraj 779 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Bulovka

    Prague, Praha 8 180 81
    Czechia

    Active - Recruiting

  • Nemocnice Na Bulovce

    Prague, Praha 8 180 81
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Hôpitaux Drôme Nord - Romans

    Romans-sur-Isère, Drôme 26102
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine 35033
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, Loire-Atlantique 44093 Cedex 1
    France

    Active - Recruiting

  • CHU de Toulouse - Hopital Larrey

    Toulouse, Midi-Pyrénées 31400
    France

    Active - Recruiting

  • Hôpital Saint Vincent-de-Paul

    Lille, Nord-Pas-de-Calais 59020
    France

    Site Not Available

  • Rosenpark Research GmbH

    Darmstadt, Hessen 64283
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, Hessen 60590
    Germany

    Active - Recruiting

  • Fachklinik Bad Bentheim

    Bad Bentheim, Niedersach 48455
    Germany

    Active - Recruiting

  • Studienzentrum an der Hase Dr. Weyergraf/Dr. Frick/T. Heiber GbR

    Bramsche, Niedersachsen 49565
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Sachsen 01307
    Germany

    Active - Recruiting

  • Fujita Health University

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • Fukuyama City Hospital

    Fukuyama, Hiroshima 721-8511
    Japan

    Active - Recruiting

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido 078-8510
    Japan

    Active - Recruiting

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa 252-0392
    Japan

    Active - Recruiting

  • Ina Central Hospital

    Ina, Nagano 396-0033
    Japan

    Active - Recruiting

  • Osaka Habikino Medical Center

    Habikino, Osaka 583-8588
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai City, Osaka 593-8324
    Japan

    Active - Recruiting

  • Kume Clinic

    Sakai City, Osaka 593-8324
    Japan

    Active - Recruiting

  • Enomoto Clinic

    Kumagaya, Saitama 360-0018
    Japan

    Active - Recruiting

  • Sugamo Sengoku Dermatology

    Toshima, Tokyo 170-0002
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • Kyoto Furitsu Medical University Hospital

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557
    Japan

    Active - Recruiting

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Distrito Federal 06720
    Mexico

    Active - Recruiting

  • Hospital de Jesús Nazareno

    Mexico City, Distrito Federal 06090
    Mexico

    Active - Recruiting

  • Trials in Medicine

    Mexico City, Distrito Federal 06700
    Mexico

    Active - Recruiting

  • Instituto Dermatologico de Jalisco

    Zapopan, Jalisco 45190
    Mexico

    Site Not Available

  • PanAmerican Clinical Research - Cuernavaca

    Cuernavaca, Morelos 62290
    Mexico

    Active - Recruiting

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Eukarya PharmaSite

    Monterrey, Nuevo León 64718
    Mexico

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Active - Recruiting

  • Scientia Investigacion Clinica S.C.

    Chihuahua, 31207
    Mexico

    Active - Recruiting

  • Arké SMO S.A de C.V

    Veracruz, 91910
    Mexico

    Active - Recruiting

  • Centrum Medyczne Evimed

    Warsaw, Mazowieckie 02-625
    Poland

    Active - Recruiting

  • Diamond Clinic

    Krakow, Małopolskie 31-559
    Poland

    Active - Recruiting

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomorskie 80-546
    Poland

    Active - Recruiting

  • "DERMED" Centrum Medyczne Sp. z o.o.

    Lodz, Łódzkie 90-265
    Poland

    Site Not Available

  • DERMED Centrum Medyczne Sp. z o.o.

    Lodz, Łódzkie 90-265
    Poland

    Active - Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las, Las Palmas 35010
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • CHOP-Centro De Especialidades De Mollabao

    Pontevedra, Pontevedra [Pontevedra] 36001
    Spain

    Active - Recruiting

  • Centro De Especialidades De Mollabao

    Pontevedra, Pontevedra [Pontevedra] 36001
    Spain

    Active - Recruiting

  • Hospital de Manises

    Manises, València 46940
    Spain

    Active - Recruiting

  • Grupo Pedro Jaén

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung 83301
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital

    Taichung City, Taichung 402
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei City, Taipei 11217
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, 300
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital-Taipei

    Taipei, 105
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Clinical Research Center of Alabama

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Arkansas Research Trials

    North Little Rock, Arkansas 72217
    United States

    Active - Recruiting

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Integrative Skin Science and Research - Location 2

    Sacramento, California 95815
    United States

    Active - Recruiting

  • UConn Health

    Farmington, Connecticut 06030-2840
    United States

    Active - Recruiting

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Allergy and Asthma Specialist

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Active - Recruiting

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Active - Recruiting

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania 19341
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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