A study to learn how safe zilucoplan is in children with generalized myasthenia gravis who participated in a previous study about zilucopla
Phase 1
- Conditions
- Generalized Myasthenia GravisMedDRA version: 21.1Level: PTClassification code: 10028417Term: Myasthenia gravis Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-502073-42-00
- Lead Sponsor
- CB Biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Participant has completed 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 withdrawal or mandatory permanent IMP discontinuation criteria in MG0014 or permanently discontinued investigational medicinal product (IMP), Participant has known positive serology for muscle-specific kinase., Participant has a known hypersensitivity to any components of the IMP., Participant has a prior history of meningococcal disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method