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

Last updated: April 14, 2024
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Allergies & Asthma

Dermatitis, Atopic

Treatment

Placebo

Lebrikizumab

Clinical Study ID

NCT05735483
18266
J2T-MC-KGBJ/DRM06-AD16
2022-501478-21-00
  • Ages 6-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Received treatment in Study KGBI and have adequately completed the study treatmentsand last visit of study KGBI.
  • For female participants of childbearing potential, highly effective contraceptive useshould be consistent with local regulations regarding the methods of contraception forthose participating in clinical studies

Exclusion

Exclusion Criteria:

  • Developed an serious adverse events (SAE) during their participation in parent studyKGBI deemed related to lebrikizumab, which in the opinion of the investigator or ofthe medical monitor could indicate that continued treatment with lebrikizumab maypresent an unreasonable risk for the participant.
  • Developed an AE during their participation in the study KGBI that was deemed relatedto lebrikizumab and led to study treatment discontinuation, which in the opinion ofthe investigator or of the medical monitor could indicate that continued treatmentwith lebrikizumab may present an unreasonable risk for the participant.
  • Met the criteria for permanent study intervention discontinuation in study KGBI, ifdeemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawalof participant from the study (for example, noncompliance, inability to complete studyassessments, etc.) Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditionsdeemed related to the study treatment will be considered related to lebrikizumab.
  • Are pregnant or breastfeeding or are planning to become pregnant or breastfeed duringthe study.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 09, 2023
Estimated Completion Date:
June 26, 2026

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

  • Fundacion Cidea

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1121ABE
    Argentina

    Site Not Available

  • 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

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • 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

    Site Not Available

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo 14784400
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13060-803
    Brazil

    Site Not Available

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo Andre, São Paulo 09060-870
    Brazil

    Active - Recruiting

  • Pesquisare Saude

    Santo André, São Paulo 09080-110
    Brazil

    Site Not Available

  • Clinica de Alergia Martti Antila

    Sorocaba, São Paulo 18040-425
    Brazil

    Site Not Available

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180
    Brazil

    Site Not Available

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • Alberta Dermasurgery Centre

    Edmonton, Alberta T6G 1C3
    Canada

    Site Not Available

  • DermEdge Research

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Detska nemocnice FN Brno

    Brno, Brno-město 613 00
    Czechia

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • CHU de Toulouse - Hopital Larrey

    Toulouse, Midi-Pyrénées 31400
    France

    Site Not Available

  • Hôpital Saint Vincent-de-Paul

    Lille, Nord-Pas-de-Calais 59020
    France

    Site Not Available

  • Rosenpark Research GmbH

    Darmstadt, Hessen 64283
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, Niedersach 48455
    Germany

    Site Not Available

  • 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

    Site Not Available

  • 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 252-0315
    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

    Site Not Available

  • 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, Małopolski 31-559
    Poland

    Site Not Available

  • 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

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las, Las Palmas 35010
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • 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

    Site Not Available

  • Grupo Pedro Jaén

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • 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 112
    Taiwan

    Site Not Available

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, 300
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital-Taipei

    Taipei, 105
    Taiwan

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • 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
    United States

    Active - Recruiting

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Allergy and Asthma Specialist

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    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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