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)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Lebrikizumab

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Buenos Aires, Buenos Aires, Argentina, 1012
      • CONEXA Investigacion Clinica S.A.
    • Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Fundación Respirar
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425DKG
      • Psoriahue
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1425
      • Instituto de Neumonologia y Dermatologia
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1027
      • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1121ABE
      • Fundacion Cidea
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DEJ
      • Fundacion Estudios Clinicos
• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Sydney Children's Hospital
    • Westmead, New South Wales, Australia, 2145
      • The Children's Hospital at Westmead
  • Queensland
    • Coorparoo, Queensland, Australia, 4151
      • Cornerstone Dermatology
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital De Clinicas De Porto Alegre
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 20241-180
      • IBPClin - Instituto Brasil de Pesquisa Clínica
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Fundacao Pio Xii - Hospital De Cancer De Barretos
    • Campinas, São Paulo, Brazil, 13060-803
      • Centro de Pesquisa Sao Lucas
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Hospital de Clínicas de Ribeirão Preto
    • Santo André, São Paulo, Brazil, 09060-870
      • Faculdade de Medicina do ABC
    • Santo André, São Paulo, Brazil, 09080-110
      • Pesquisare Saude
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Clinica de Alergia Martti Antila
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute
  • Ontario
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research
• Czechia
  • Brno-město
    • Brno, Brno-město, Czechia, 613 00
      • Detska nemocnice FN Brno
  • Praha 8
    • Prague, Praha 8, Czechia, 180 81
      • Fakultni nemocnice Bulovka
• France
  • Drôme
    • Romans-sur-Isère, Drôme, France, 26102
      • Hôpitaux Drôme Nord - Romans
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59020
      • Hôpital Saint Vincent-De-Paul
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093 Cedex 1
      • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31400
      • CHU de Toulouse - Hôpital Larrey
• Germany
  • Hesse
    • Darmstadt, Hesse, Germany, 64283
      • Rosenpark Research GmbH
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitatsklinikum Frankfurt
  • Niedersach
    • Bad Bentheim, Niedersach, Germany, 48455
      • Fachklinik Bad Bentheim
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitatsklinikum Munster
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden
• Japan
  • Aichi-ken
    • Toyoake, Aichi-ken, Japan, 470-1192
      • Fujita Health University
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 721-8511
      • Fukuyama City Hospital
    • Hiroshima, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 078-8510
      • Asahikawa Medical College Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0315
      • National Hospital Organization Sagamihara National Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • University Hospital,Kyoto Prefectural University of Medicine
  • Nagano
    • Ina, Nagano, Japan, 396-0033
      • Ina Central Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8557
      • Okayama City General Medical Center Okayama City Hospital
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Osaka Habikino Medical Center
    • Sakai, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
  • Saitama
    • Kumagaya, Saitama, Japan, 360-0018
      • Enomoto Clinic
  • Tokyo
    • Toshima City, Tokyo, Japan, 170-0002
      • Sugamo Sengoku Dermatology
• Mexico
  • Chihuahua
    • Chihuahua City, Chihuahua, Mexico, 31207
      • Scientia Investigacion Clinica S.C.
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45190
      • Instituto Dermatologico de Jalisco
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06720
      • Hospital Infantil de Mexico Federico Gomez
    • Mexico City, Mexico City, Mexico, 06090
      • Hospital de Jesús Nazareno
    • Mexico City, Mexico City, Mexico, 06700
      • Trials in Medicine
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • PanAmerican Clinical Research - Cuernavaca
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • Monterrey, Nuevo León, Mexico, 64718
      • Eukarya PharmaSite
  • Veracruz
    • Veracruz, Veracruz, Mexico, 91910
      • Arké SMO S.A de C.V
• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-625
      • Centrum Medyczne Evimed
  • Małopolski
    • Krakow, Małopolski, Poland, 31-559
      • Diamond Clinic
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-265
      • DERMED Centrum Medyczne Sp. z o.o.
• Spain
  • Barcelona [Barcelona]
    • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
      • Hospital Sant Joan de Déu
  • Las Palmas
    • Las, Las Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrín
  • Madrid
    • Madrid, Madrid, Spain, 28041
      • Hospital Universitario 12 de Octubre
    • Madrid, Madrid, Spain, 28046
      • Hospital Universitario La Paz
    • Madrid, Madrid, Spain, 28006
      • Grupo Pedro Jaén
    • Madrid, Madrid, Spain, 28009
      • Hospital Infantil Universitario Niño Jesús
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quirónsalud Madrid
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra
  • Pontevedra [Pontevedra]
    • Pontevedra, Pontevedra [Pontevedra], Spain, 36001
      • CHOP-Centro De Especialidades De Mollabao
  • València
    • Manises, València, Spain, 46940
      • Hospital de Manises
• Taiwan
  • Hsinchu
    • Hsinchu, Hsinchu, Taiwan, 300
      • National Taiwan University Hospital - Hsinchu branch
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Chang Gung Memorial Hospital at Kaohsiung
  • Taichung
    • Taichung, Taichung, Taiwan, 402
      • Chung Shan Medical University Hospital
  • Taipei
    • Taipei, Taipei, Taiwan, 11217
      • Taipei Veterans General Hospital
    • Taipei, Taipei, Taiwan, 10002
      • National Taiwan University Hospital
  • Taoyuan
    • Taoyuan, Taoyuan, Taiwan, 333
      • Chang Gung Medical Foundation-Linkou Branch
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • Arkansas
    • North Little Rock, Arkansas, United States, 72217
      • Arkansas Research Trials
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research - Location 2
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy and Asthma Specialist
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan, PLC
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Bellaire, Texas, United States, 77401
      • The University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab; Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.	Drug: Placebo; Administered SC; Drug: Lebrikizumab; Administered SC; Other Names: LY3650150
Experimental: 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.	Drug: Placebo; Administered SC; Drug: Lebrikizumab; Administered SC; Other Names: LY3650150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)	Baseline through Week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ	Baseline to Week 52
Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ	Baseline to Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score	Baseline, Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)	Baseline, Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI	Baseline, Week 52
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI	Baseline, Week 52
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)	Baseline, Week 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ	Baseline to Week 52
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• 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)

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; lebrikizumab
• Other Study ID Numbers: 18266; J2T-MC-KGBJ/DRM06-AD16 (Other Identifier: Eli Lilly and Company); 2022-501478-21-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No