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Clinical Trials in Italy / NCT06055959
Recruiting Phase 2/3

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

NCT06055959 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2/3
Started
2024-10-16
Last updated
2026-07-31

Condition(s) studied

Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

Zilucoplan →

Zilucoplan: Zilucoplan will be administered subcutaneously to pediatric study participants.

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: * Participant has known positive serology for muscle-specific kinase * 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 had a thymectomy within 6 months prior to Baseline * Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator * Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Mg0014 50168 Chicago Illinois Withdrawn
Mg0014 50574 Flower Mound Texas Withdrawn
Mg0014 40144 Milan Italy Recruiting
Mg0014 40774 Katowice Poland Recruiting
Mg0014 40218 Warsaw Poland Active Not Recruiting
Mg0014 20104 Seoul South Korea Withdrawn
Mg0014 20220 Seoul South Korea Recruiting
Mg0014 40735 Glasgow United Kingdom Recruiting
Mg0014 40736 London United Kingdom Recruiting

More UCB Biopharma SRL trials in Italy

Other trials for the same condition

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 NCT06055959 on ClinicalTrials.gov ↗ ← All trials in Italy