Clinical Trials in Poland / NCT06435312
Enrolling by invitation
Phase 3
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
NCT06435312 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Generalized Myasthenia Gravis
Investigational drug(s) / intervention(s)
Zilucoplan: Zilucoplan will be administered subcutaneously to pediatric study participants
Study 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
Eligibility
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
Primary outcome measure(s)
- Occurence of treatment emergent adverse events during the course of the study — Baseline (Day 1) to Safety Follow-up (up to Week 60)
An adverse event (AE) is any untoward medical occurence in a patient or clinical investigation where the study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. - Occurence of treatment-emergent serious adverse events (TESAEs) — Baseline (Day 1) to Safety Follow-up (up to Week 60)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening Requires inpatient hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical event. - Occurence of treatment-emergent advserse events leading to permanent withdrawal of investigational medicinal product — Baseline (Day 1) to Safety Follow-up (up to Week 60)
An adverse event (AE) is any untoward medical occurence in a participant or clinical investigation administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication. - Occurence of treatment-emergent infections — Baseline (Day 1) to Safety Follow-up (up to Week 60)
Percentage of participants who experienced treatment-emergent infections as adverse events. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06435312 on ClinicalTrials.gov ↗ ← All trials in Poland