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

UCB

Status and phase

Begins enrollment in 1 month

Phase 3

Conditions

Generalized Myasthenia Gravis

Treatments

Drug: Zilucoplan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06435312

2022-502073-42-00 (Other Identifier)

MG0015

Details and patient eligibility

About

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

Enrollment

8 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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