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Recruiting Phase 2/3 NCT06055959

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

Phase 2/3 – combined trial
Conditions: Generalized Myasthenia Gravis

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
Zilucoplan
DRUG
Locations 9
Italy (1)
Mg0014 40144
Milan
Poland (2)
Mg0014 40774
Katowice
Mg0014 40218
Warsaw
ACTIVE_NOT_RECRUITING
South Korea (2)
Mg0014 20104
Seoul
Mg0014 20220
Seoul
United Kingdom (2)
Mg0014 40735
Glasgow
Mg0014 40736
London
United States (2)
Mg0014 50168
Chicago , Illinois
WITHDRAWN
Mg0014 50574
Flower Mound , Texas
WITHDRAWN
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
16.10.2024
Completion date
25.12.2026
Registry ID
NCT06055959
Source
clinicaltrials.gov
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