Long-term study of lebrikizumab in children with atopic dermatitis
Tests lebrikizumab over time in children aged 6 months to under 18 with eczema.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Bay City, Bellaire, Birmingham, Boise, Boston, Charleston, Chicago, Fairborn, Farmington, Fountain Valley, Jacksonville, Lebanon, Los Angeles, Milwaukee, North Little Rock, Owensboro, Phoenix, Sacramento, San Antonio, Tampa, and Ypsilanti, United StatesSee the 21 sites
- Phase
- Phase 3
Where in United States
- Great Lakes Research Group, Inc.Bay City, United StatesNo longer taking part
- The University of Texas Health Science Center at HoustonBellaire, United StatesNo longer taking part
- Clinical Research Center of AlabamaBirmingham, United StatesNo longer taking part
- Treasure Valley Medical ResearchBoise, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Wright State PhysiciansFairborn, United StatesNo longer taking part
- UConn HealthFarmington, United StatesNo longer taking part
- First OC DermatologyFountain Valley, United StatesNo longer taking part
- Solutions Through Advanced ResearchJacksonville, United StatesNo longer taking part
- Dartmouth Hitchcock Medical CenterLebanon, United StatesNo longer taking part
- Dermatology Research AssociatesLos Angeles, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Arkansas Research TrialsNorth Little Rock, United StatesNo longer taking part
- Allergy and Asthma SpecialistOwensboro, United StatesNo longer taking part
- Phoenix Children s HospitalPhoenix, United StatesNo longer taking part
- Integrative Skin Science and Research - Location 2Sacramento, United StatesNo longer taking part
- Texas Dermatology and Laser SpecialistsSan Antonio, United StatesNo longer taking part
- ForCare Clinical ResearchTampa, United StatesNo longer taking part
- Respiratory Medicine Research Institute of Michigan, PLCYpsilanti, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT05735483EU 2022-501478-21-00
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.