Long-term safety of zilucoplan in children with generalized myasthenia gravis
Tests daily zilucoplan injections in teenagers with generalized myasthenia gravis, a muscle weakness disease.
Plain-language title generated from the registry record
Registry title: An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Key facts
- Where
- Milan, ItalySee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT06435312, who can take part
Where in Italy
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UCB Biopharma SRL
- Trial code
- NCT06435312EU 2022-502073-42-00
- Record updated
- 2 October 2026
- Original description
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 participantsRead full original descriptionShow less
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
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
Inclusion: 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: Participant has a prior history of meningococcal disease; Participant has known hypersensitivity to any components of the IMP; 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.