Набор по приглашению NCT05735483
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
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lebrikizumab, Placebo.
- Кому может быть актуально
- Состояния в реестре: Atopic Dermatitis, Eczema. Базовые параметры: 6 мес. — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Аргентина, Австралия, Бразилия, Канада +8
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Вмешательства
- Препарат Lebrikizumab
Administered SC - Препарат Placebo
Administered SC
Первичные конечные точки
- Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) [Срок оценки: Baseline through Week 52]
Вторичные конечные точки (9)
- Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ [Срок оценки: Baseline to Week 52]
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ [Срок оценки: Baseline to Week 52]
- Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ [Срок оценки: Baseline to Week 52]
- Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ [Срок оценки: Baseline to Week 52]
- Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score [Срок оценки: Baseline, Week 52]
- Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD) [Срок оценки: Baseline, Week 52]
- Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI [Срок оценки: Baseline, Week 52]
- Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI [Срок оценки: Baseline, Week 52]
- Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) [Срок оценки: Baseline, Week 52]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 21 центр
- Clinical Research Center of Alabama — Birmingham
- Phoenix Children's Hospital — Phoenix
- Arkansas Research Trials — North Little Rock
- First OC Dermatology — Fountain Valley
- Dermatology Research Associates — Los Angeles
- Integrative Skin Science and Research - Location 2 — Sacramento
- UConn Health — Farmington
- Solutions Through Advanced Research — Jacksonville
- … и ещё 13 центров
Япония · 12 центров
- Fujita Health University — Toyoake
- Fukuyama City Hospital — Fukuyama
- Hiroshima University Hospital — Hiroshima
- Asahikawa Medical College Hospital — Asahikawa
- National Hospital Organization Sagamihara National Hospital — Sagamihara
- University Hospital,Kyoto Prefectural University of Medicine — Kyoto
- Ina Central Hospital — Ina
- Okayama City General Medical Center Okayama City Hospital — Okayama
- … и ещё 4 центра
Испания · 10 центров
- Hospital Sant Joan de Déu — Esplugues de Llobregat
- Hospital Universitario de Gran Canaria Doctor Negrín — Las
- … и ещё 8 центров
Мексика · 9 центров
- Scientia Investigacion Clinica S.C. — Chihuahua City
- Instituto Dermatologico de Jalisco — Zapopan
- Hospital de Jesús Nazareno — Mexico City
- Trials in Medicine — Mexico City
- Hospital Infantil de Mexico Federico Gomez — Mexico City
- PanAmerican Clinical Research - Cuernavaca — Cuernavaca
- Eukarya PharmaSite — Monterrey
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey
- … и ещё 1 центр
Бразилия · 8 центров
- IBPClin - Instituto Brasil de Pesquisa Clínica — Rio de Janeiro
- Hospital de Clinicas de Porto Alegre — Porto Alegre
- Fundação Pio XII - Hospital de Câncer de Barretos — Barretos
- Centro de Pesquisa Sao Lucas — Campinas
- Hospital de Clínicas de Ribeirão Preto — Ribeirão Preto
- Faculdade de Medicina do ABC — Santo André
- Pesquisare Saude — Santo André
- Clinica de Alergia Martti Antila — Sorocaba
Аргентина · 7 центров
- CONEXA Investigacion Clinica S.A. — Buenos Aires
- Fundación Respirar — Buenos Aires
- Instituto de Neumonología Y Dermatología — Ciudad Autonoma de Buenos Aire
- Psoriahue — Ciudad Autonoma de Buenos Aire
- Centro de Investigaciones Metabólicas (CINME) — Ciudad Autónoma de Buenos Aires
- Fundacion Cidea — Buenos Aires
- Fundacion Estudios Clinicos — Rosario
Тайвань · 6 центров
Список центров уточняется — проверьте первичный протокол.
Германия · 5 центров
- Rosenpark Research GmbH — Darmstadt
- Universitätsklinikum Frankfurt — Frankfurt am Main
- Fachklinik Bad Bentheim — Bad Bentheim
- Universitätsklinikum Münster — Münster
- Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
Австралия · 4 центра
- Sydney Children's Hospital — Randwick
- The Children's Hospital at Westmead — Westmead
- Cornerstone Dermatology — Coorparoo
- Veracity Clinical Research Pty Ltd — Woolloongabba
Франция · 4 центра
- Hôpitaux Drôme Nord - Romans — Romans-sur-Isère
- Hôpital Saint Vincent-de-Paul — Lille
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes
- CHU de Toulouse - Hopital Larrey — Toulouse
Польша · 4 центра
- Centrum Medyczne Evimed — Warsaw
- Diamond Clinic — Krakow
- Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
- DERMED Centrum Medyczne Sp. z o.o. — Lodz
Канада · 2 центра
- Dermatology Research Institute — Calgary
- DermEdge Research — Mississauga
Чехия · 2 центра
- Detska nemocnice FN Brno — Brno
- Fakultni nemocnice Bulovka — Prague
Идентификаторы
NCT: NCT05735483 · 18266 · J2T-MC-KGBJ/DRM06-AD16 · 2022-501478-21-00