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Clinical Trials in the USA / NCT05735483
Enrolling by invitation Phase 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

NCT05735483 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2023-03-09
Last updated
2026-07-30

Condition(s) studied

Atopic DermatitisEczema

Investigational drug(s) / intervention(s)

LebrikizumabPlacebo

Lebrikizumab: Administered SC

Placebo: Administered SC

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.

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.

Eligibility

Sex
ALL
Min age
6 Months
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (94)

FacilityCityRegionStatus
Clinical Research Center of Alabama Birmingham Alabama
Phoenix Children's Hospital Phoenix Arizona
Arkansas Research Trials North Little Rock Arkansas
First OC Dermatology Fountain Valley California
Dermatology Research Associates Los Angeles California
Integrative Skin Science and Research - Location 2 Sacramento California
UConn Health Farmington Connecticut
Solutions Through Advanced Research Jacksonville Florida
ForCare Clinical Research Tampa Florida
Treasure Valley Medical Research Boise Idaho
Northwestern University Chicago Illinois
Allergy and Asthma Specialist Owensboro Kentucky
Massachusetts General Hospital Boston Massachusetts
Great Lakes Research Group, Inc. Bay City Michigan
Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Wright State Physicians Fairborn Ohio
Medical University of South Carolina Charleston South Carolina
The University of Texas Health Science Center at Houston Bellaire Texas
Texas Dermatology and Laser Specialists San Antonio Texas
Medical College of Wisconsin Milwaukee Wisconsin
CONEXA Investigacion Clinica S.A. Buenos Aires Buenos Aires
Fundación Respirar Buenos Aires Buenos Aires
Instituto de Neumonología Y Dermatología Ciudad Autonoma de Buenos Aire Buenos Aires
Psoriahue Ciudad Autonoma de Buenos Aire Buenos Aires
Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aires Buenos Aires
Fundacion Cidea Buenos Aires Buenos Aires F.D.
Fundacion Estudios Clinicos Rosario Santa Fe Province
Sydney Children's Hospital Randwick New South Wales
The Children's Hospital at Westmead Westmead New South Wales
Cornerstone Dermatology Coorparoo Queensland
Veracity Clinical Research Pty Ltd Woolloongabba Queensland
IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Rio de Janeiro
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
Fundação Pio XII - Hospital de Câncer de Barretos Barretos São Paulo
Centro de Pesquisa Sao Lucas Campinas São Paulo
Hospital de Clínicas de Ribeirão Preto Ribeirão Preto São Paulo
Faculdade de Medicina do ABC Santo André São Paulo
Pesquisare Saude Santo André São Paulo
Clinica de Alergia Martti Antila Sorocaba São Paulo

+ 54 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05735483 on ClinicalTrials.gov ↗ ← All trials in the USA