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By invitation only Phase 3 NCT05735483

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to

Phase 3 – large-scale trial before approval
Conditions: Atopic Dermatitis Eczema

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 13
Argentina (1)
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire , Buenos Aires
Australia (1)
Sydney Children's Hospital
Randwick , New South Wales
Brazil (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre , Rio Grande do Sul
Canada (1)
Dermatology Research Institute
Calgary , Alberta
Czech Republic (1)
Detska nemocnice FN Brno
Brno , Brno-město
France (1)
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère , Drôme
Germany (1)
Rosenpark Research GmbH
Darmstadt , Hesse
Japan (1)
Fujita Health University
Toyoake , Aichi-ken
Mexico (1)
Instituto Dermatologico de Jalisco
Zapopan , Jalisco
Poland (1)
Centrum Medyczne Evimed
Warsaw , Masovian Voivodeship
Spain (1)
Hospital Sant Joan de Déu
Esplugues de Llobregat , Barcelona [Barcelona]
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist , Kaohsiung
United States (1)
Clinical Research Center of Alabama
Birmingham , Alabama
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Months
Maximum age
18 Years
Healthy volunteers
No
Start date
09.03.2023
Completion date
01.04.2029
Registry ID
NCT05735483
Source
anzctr
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