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NCT06055959RecruitingPhase 2/3

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

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

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
8 (estimated)
First submitted
20 Sept 2023
Start date
16 Oct 2024
Primary completion date
12 May 2027
Lead sponsor
UCB Biopharma SRL
NCT number
NCT06055959
EU CT number
2022-502072-23-00
EudraCT number
2022-502072-23

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 8
  • From 16 Oct 2024 to the primary completion date, 12 May 2027
  • 9 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Participant has known positive serology for muscle-specific kinase
  • Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator

Who the study is looking for

  • 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)

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Mg0014 40735
Coordinator of this site? Confirm its status
GlasgowUnited KingdomRecruiting
Mg0014 40736
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Mg0014 20104
Coordinator of this site? Confirm its status
SeoulSouth KoreaWithdrawn
Mg0014 20220
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Neurologia Śląska Centrum Medyczne
Coordinator of this site? Confirm its status
KatowicePolandRecruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Mg0014 50168
Coordinator of this site? Confirm its status
ChicagoUnited StatesWithdrawn
Mg0014 50574
Coordinator of this site? Confirm its status
DentonUnited StatesWithdrawn

This page is information, not medical advice. Discuss any trial with your doctor.