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By invitation only Phase 3 NCT06435312

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

Phase 3 – large-scale trial before approval
Conditions: Generalized Myasthenia Gravis

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
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
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
Interventions
Zilucoplan
DRUG
Locations 7
Italy (1)
Mg0015 40144
Milan
Poland (2)
Mg0015 40774
Katowice
Mg0015 40218
Warsaw
South Korea (2)
Mg0015 20104
Seoul
Mg0015 20220
Seoul
United Kingdom (2)
Mg0015 40735
Glasgow
Mg0015 40736
London
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
19.11.2024
Completion date
19.11.2027
Registry ID
NCT06435312
Source
clinicaltrials.gov
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