MG0015
MG0015
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
Brief summary
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
Medical Condition
Generalized Myasthenia Gravis
Min. Age
12
Years
Max. Age
-
Who Can Join?
All
Status
Not yet recruiting
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
Study Medication Description
Study Medication:
ZILBRYSQ®
Other Descriptive Name:
zilucoplan
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
August 2024
Planned Start Date of Enrollment
December 2027
Planned Study Completion Date
General Information
Study ID:
MG0015
Phase:
Phase 3