NCT06435312Enrolling by invitationPhase 3
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 23 May 2024
- Start date
- 19 Nov 2024
- Primary completion date
- 26 Oct 2027
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Myasthenia gravis
- NCT number
- NCT06435312
- EU CT number
- 2022-502073-42-00
- EudraCT number
- 2022-502073-42
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 8
- From 19 Nov 2024 to the primary completion date, 26 Oct 2027
- 6 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has a prior history of meningococcal disease
Other illness
- Participant has known hypersensitivity to any components of the IMP
Other
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mg0015 40735 Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Mg0015 40736 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Mg0015 20220 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.