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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502073-42-00

Acronym

MG0015

Enrollment

Registered

2023-12-14

Start date

2025-08-18

Completion date

Unknown

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

• Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study • Occurrence of treatment-emergent serious adverse events (TESAEs) • Occurrence of TEAEs leading to permanent withdrawal of investigational medicinal product (IMP) • Occurrence of treatment-emergent infections

Detailed description

• Plasma concentration of zilucoplan (ZLP) at Week 52 • Sheep red blood cell (sRBC) lysis activity at Week 52 • Complement component 5 (C5) levels at Week 52 • Myasthenia Gravis Activities of Daily Living (MG ADL) score at Week 52 • Quantitative Myasthenia Gravis (QMG) score at Week 52

Interventions

DRUGZilucoplan sodium

DRUGZilbrysq 32.4 mg solution for injection in pre-filled syringe

DRUGZilbrysq 16.6 mg solution for injection in pre-filled syringe

DRUGZilbrysq 23 mg solution for injection in pre-filled syringe

DRUG-

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
• Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study • Occurrence of treatment-emergent serious adverse events (TESAEs) • Occurrence of TEAEs leading to permanent withdrawal of investigational medicinal product (IMP) • Occurrence of treatment-emergent infections	—

Secondary

Measure	Time frame
• Plasma concentration of zilucoplan (ZLP) at Week 52 • Sheep red blood cell (sRBC) lysis activity at Week 52 • Complement component 5 (C5) levels at Week 52 • Myasthenia Gravis Activities of Daily Living (MG ADL) score at Week 52 • Quantitative Myasthenia Gravis (QMG) score at Week 52	—

Countries

Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026