Actively Recruiting
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Led by UCB Biopharma SRL · Updated on 2026-05-08
8
Participants Needed
9
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized myasthenia gravis (gMG).
CONDITIONS
Official Title
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 12 to <18 years of age in the USA or 2 to <18 years of age in the rest of the world at the time of consent/assent
- Diagnosis of generalized myasthenia gravis confirmed by positive acetylcholine receptor antibody test prior to screening
- Clinical classification of Myasthenia Gravis Foundation of America II to IV at screening
- For adolescents 12 to <18 years, an MG-activities of daily living (MG-ADL) total score of 6 or more at screening
- For children 2 to <12 years (non-USA), documented weakness in at least one limb, neck, or bulbar muscle at screening
- Documented vaccination against meningococcal infections within 3 years prior to study start or appropriate prophylactic antibiotic treatment if not fully vaccinated
You will not qualify if you...
- Known positive serology for muscle-specific kinase
- Any medical or psychiatric condition that could compromise ability to participate, as judged by the investigator
- Thymectomy within 6 months prior to baseline
- Minimal manifestation status of myasthenia gravis based on investigator judgment
- Current or recent systemic infection within 2 weeks prior to baseline or infection requiring intravenous antibiotics within 4 weeks prior to baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Mg0014 50168
Chicago, Illinois, United States, 60611
Withdrawn
2
Mg0014 50574
Denton, Texas, United States, 76208
Withdrawn
3
Mg0014 40144
Milan, Italy
Actively Recruiting
4
Mg0014 40774
Katowice, Poland
Actively Recruiting
5
Mg0014 40218
Warsaw, Poland
Active, Not Recruiting
6
Mg0014 20104
Seoul, South Korea
Actively Recruiting
7
Mg0014 20220
Seoul, South Korea
Actively Recruiting
8
Mg0014 40735
Glasgow, United Kingdom
Actively Recruiting
9
Mg0014 40736
London, United Kingdom
Actively Recruiting
Research Team
U
UCB Cares
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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