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

Enrolling by invitation · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

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

Key facts

Study ID

NCT06435312

Run by

UCB Biopharma SRL

People needed

8

Starts

2024-11-19

Expected to finish

2027-11-19

Last updated by the study team

2026-07-31

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mg0015 40144 — Milan, Italy
• Mg0015 40774 — Katowice, Poland
• Mg0015 40218 — Warsaw, Poland
• Mg0015 20220 — Seoul, South Korea
• Mg0015 40735 — Glasgow, United Kingdom
• Mg0015 40736 — London, United Kingdom

Full record on ClinicalTrials.gov

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