NCT05735483Enrolling by invitationPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 9 Mar 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05735483
- EU CT number
- 2022-501478-21-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 338
- From 9 Mar 2023 to the primary completion date, 31 Dec 2027
- 93 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
Who the study is looking for
- 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
Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (93)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion Cidea Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CONEXA Investigacion Clinica S.A. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Psoriahue Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| Instituto de Neumonología Y Dermatología Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Fundacion Estudios Clinicos Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Cornerstone Dermatology Coordinator of this site? Confirm its status | Coorparoo | Australia | Unknown status |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Veracity Clinical Research Pty Ltd Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Fundação Pio XII - Hospital de Câncer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital de Clínicas de Ribeirão Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| IBPClin - Instituto Brasil de Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Faculdade de Medicina do ABC Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Pesquisare Saude Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Clinica de Alergia Martti Antila Coordinator of this site? Confirm its status | Sorocaba | Brazil | Unknown status |
| Dermatology Research Institute Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| DermEdge Research Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Active, not recruiting |
| Fakultni nemocnice Bulovka Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Rosenpark Research Gmbh Coordinator of this site? Confirm its status | Darmstadt | Germany | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Active, not recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Münster | Germany | Active, not recruiting |
| Hospital Sant Joan de Déu Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario de Gran Canaria Dr Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Active, not recruiting |
| Grupo Dermatológico y Estético Pedro Jaén S.A Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital de Manises Coordinator of this site? Confirm its status | Manises | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Hopitaux Drome Nord Coordinator of this site? Confirm its status | Romans-Sur-Isere | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Not yet recruiting |
| Asahikawa Medical College Hospital Coordinator of this site? Confirm its status | Asahikawa | Japan | Unknown status |
| Fukuyama City Hospital Coordinator of this site? Confirm its status | Fukuyama | Japan | Unknown status |
| Osaka Habikino Medical Center Coordinator of this site? Confirm its status | Habikino | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Ina Central Hospital Coordinator of this site? Confirm its status | Ina | Japan | Unknown status |
| Enomoto Clinic Coordinator of this site? Confirm its status | Kumagaya | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Okayama City General Medical Center Okayama City Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| National Hospital Organization Sagamihara National Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Dermatology and Ophthalmology Kume Clinic Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Sugamo Sengoku Dermatology Coordinator of this site? Confirm its status | Toshima City | Japan | Unknown status |
| Fujita Health University Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| PanAmerican Clinical Research - Cuernavaca Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Trials in Medicine Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Infantil de Mexico Federico Gomez Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital de Jesús Nazareno Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Eukarya PharmaSite Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Instituto Dermatologico de Jalisco Coordinator of this site? Confirm its status | Zapopan | Mexico | Unknown status |
| Diamond Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Evimed Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| National Taiwan University Hospital - Hsinchu branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Great Lakes Research Group, Inc. Coordinator of this site? Confirm its status | Bay City | United States | Unknown status |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Clinical Research Center of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Treasure Valley Medical Research Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Wright State Physicians Coordinator of this site? Confirm its status | Fairborn | United States | Unknown status |
| UConn Health Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| First OC Dermatology Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Solutions Through Advanced Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Dermatology Research Associates Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Arkansas Research Trials Coordinator of this site? Confirm its status | North Little Rock | United States | Unknown status |
| Allergy and Asthma Specialist Coordinator of this site? Confirm its status | Owensboro | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Integrative Skin Science and Research - Location 2 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Texas Dermatology and Laser Specialists Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| ForCare Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Respiratory Medicine Research Institute of Michigan, PLC Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.