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Само по покана Фаза 3 NCT05735483

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Atopic Dermatitis Eczema

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 13
Argentina (1)
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire , Buenos Aires
Австралия (1)
Sydney Children's Hospital
Randwick , New South Wales
Бразилия (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre , Rio Grande do Sul
Канада (1)
Dermatology Research Institute
Calgary , Alberta
Чехия (1)
Detska nemocnice FN Brno
Brno , Brno-město
Франция (1)
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère , Drôme
Германия (1)
Rosenpark Research GmbH
Darmstadt , Hesse
Япония (1)
Fujita Health University
Toyoake , Aichi-ken
Mexico (1)
Instituto Dermatologico de Jalisco
Zapopan , Jalisco
Полша (1)
Centrum Medyczne Evimed
Warsaw , Masovian Voivodeship
Испания (1)
Hospital Sant Joan de Déu
Esplugues de Llobregat , Barcelona [Barcelona]
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist , Kaohsiung
САЩ (1)
Clinical Research Center of Alabama
Birmingham , Alabama
Технически детайли
Статус
Само по покана
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
6 Months
Максимална възраст
18 Years
Здрави доброволци
Не
Начална дата
09.03.2023
Крайна дата
01.04.2029
Регистрационен номер
NCT05735483
Източник
anzctr
Запитване за медицински туризъм

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