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