By InvitationPhase 3

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

Italy, Poland, South Korea8 participantsStarted 2024-11-19

Plain-language summary

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

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurence of treatment emergent adverse events during the course of the study

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Occurence of treatment-emergent serious adverse events (TESAEs)

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Occurence of treatment-emergent advserse events leading to permanent withdrawal of investigational medicinal product

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Occurence of treatment-emergent infections

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Trial details

NCT IDNCT06435312

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-26

View on ClinicalTrials.gov More Generalized Myasthenia Gravis trials

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Occurence of treatment emergent adverse events during the course of the study

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Occurence of treatment-emergent serious adverse events (TESAEs)

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Occurence of treatment-emergent advserse events leading to permanent withdrawal of investigational medicinal product

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)

Occurence of treatment-emergent infections

Timeframe: Baseline (Day 1) to Safety Follow-up (up to Week 60)