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Само по покана Фаза 3 NCT06435312

An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Generalized Myasthenia Gravis

Спонсор: UCB Biopharma SRL

Налично на: БГ
Обобщение
The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants
Кой може да участва
Inclusion Criteria: United States of America (USA) specific inclusion criterion: \- Participant must be ≥ 12 years of age at the time of signing the Informed Consent/Assent according to local regulation. Rest of World (ROW) specific inclusion criterion: \- Participant must be ≥ 2 years of age at the time of signing the Informed Consent/Assent according to local regulation. Global specific inclusion criteria: * Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion * Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care Exclusion Criteria: * Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP * Participant has known positive serology for muscle-specific kinase * Participant has known hypersensitivity to any components of the IMP * Participant has a prior history of meningococcal disease
Интервенции
Zilucoplan
DRUG
Места на провеждане 7
Италия (1)
Mg0015 40144
Milan
Полша (2)
Mg0015 40774
Katowice
Mg0015 40218
Warsaw
Южна Корея (2)
Mg0015 20104
Seoul
Mg0015 20220
Seoul
Великобритания (2)
Mg0015 40735
Glasgow
Mg0015 40736
London
Технически детайли
Статус
Само по покана
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
19.11.2024
Крайна дата
19.11.2027
Регистрационен номер
NCT06435312
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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