Tests zilucoplan in young people with generalized myasthenia gravis
Tests zilucoplan, a subcutaneous drug, in people aged 12 to 17 with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Key facts
- Where
- Glasgow and London, United KingdomSee the 2 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT06055959, who can take part
Where in United Kingdom
- Mg0014 40735Glasgow, United KingdomTaking people
- Mg0014 40736London, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UCB Biopharma SRL
- Trial code
- NCT06055959EU 2022-502072-23-00
- Record updated
- 5 November 2026
- Original description
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).Read full original descriptionShow less
A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
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).
Inclusion: United States of America (USA) specific inclusion criterion:; Participant must be 12 to <18 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 to <18 years of age at the time of signing the Informed consent/assent according to local regulation; Global inclusion criteria:; Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by a prior positive serologic test result to acetylcholine receptor (AChR) prior to Screening; Participant meets the criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening; Participants with gMG, including:; An MG-activities of daily living (MG-ADL) total score of 6 or more in adolescents from 12 years to <18 years of age at Screening; Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to <12 years of age at Screening (does not apply to US); Documented vaccination against meningococcal infections within 3 years prior to study start. If not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s).
Exclusion: Participant has had a thymectomy within 6 months prior to Baseline; Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline; Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study; Participant has known positive serology for muscle-specific kinase; Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator.