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
3 other identifiers
interventional
310
13 countries
94
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2023
Longer than P75 for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 6, 2026
May 1, 2026
4.7 years
February 10, 2023
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Baseline through Week 52
Secondary Outcomes (9)
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 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
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
- +4 more secondary outcomes
Study Arms (2)
Lebrikizumab
EXPERIMENTALParticipants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
Lebrikizumab - Optional Extension Period (OEP)
EXPERIMENTALDuring the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Arkansas Research Trials
North Little Rock, Arkansas, 72217, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Integrative Skin Science and Research - Location 2
Sacramento, California, 95815, United States
UConn Health
Farmington, Connecticut, 06030, United States
Solutions Through Advanced Research
Jacksonville, Florida, 32256, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Northwestern University
Chicago, Illinois, 60611, United States
Allergy and Asthma Specialist
Owensboro, Kentucky, 42301, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
CONEXA Investigacion Clinica S.A.
Buenos Aires, Buenos Aires, 1012, Argentina
Fundación Respirar
Buenos Aires, Buenos Aires, C1426ABP, Argentina
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1425, Argentina
Psoriahue
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425DKG, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1027, Argentina
Fundacion Cidea
Buenos Aires, Buenos Aires F.D., C1121ABE, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ, Argentina
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Cornerstone Dermatology
Coorparoo, Queensland, 4151, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, Rio de Janeiro, 20241-180, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-803, Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14051-140, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
Pesquisare Saude
Santo André, São Paulo, 09080-110, Brazil
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425, Brazil
Dermatology Research Institute
Calgary, Alberta, T2J 7E1, Canada
DermEdge Research
Mississauga, Ontario, L4Y 4C5, Canada
Detska nemocnice FN Brno
Brno, Brno-město, 613 00, Czechia
Fakultni nemocnice Bulovka
Prague, Praha 8, 180 81, Czechia
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, Drôme, 26102, France
Hôpital Saint Vincent-de-Paul
Lille, Hauts-de-France, 59020, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093 Cedex 1, France
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, 31400, France
Rosenpark Research GmbH
Darmstadt, Hesse, 64283, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Niedersach, 48455, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307, Germany
Fujita Health University
Toyoake, Aichi-ken, 470-1192, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, 252-0315, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Ina Central Hospital
Ina, Nagano, 396-0033, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, 700-8557, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, 593-8324, Japan
Enomoto Clinic
Kumagaya, Saitama, 360-0018, Japan
Sugamo Sengoku Dermatology
Toshima City, Tokyo, 170-0002, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, Chihuahua, 31207, Mexico
Instituto Dermatologico de Jalisco
Zapopan, Jalisco, 45190, Mexico
Hospital de Jesús Nazareno
Mexico City, Mexico City, 06090, Mexico
Trials in Medicine
Mexico City, Mexico City, 06700, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, 06720, Mexico
PanAmerican Clinical Research - Cuernavaca
Cuernavaca, Morelos, 62290, Mexico
Eukarya PharmaSite
Monterrey, Nuevo León, 64718, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Arké SMO S.A de C.V
Veracruz, Veracruz, 91910, Mexico
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625, Poland
Diamond Clinic
Krakow, Małopolski, 31-559, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
DERMED Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265, Poland
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las, Las Palmas, 35010, Spain
Grupo Pedro Jaén
Madrid, Madrid, 28006, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Pontevedra [Pontevedra], 36001, Spain
Hospital de Manises
Manises, València, 46940, Spain
National Taiwan University Hospital - Hsinchu branch
Hsinchu, Hsinchu, 300, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, Taichung, 402, Taiwan
National Taiwan University Hospital
Taipei, Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- All participants receive Lebrikizumab during the 16-week blinded treatment period. At Week 18, participants receive open-label lebrikizumab. From Week 52 onward, doses may be blinded or open-label.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 21, 2023
Study Start
March 9, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2029
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.