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Looking for participantsPhase2/Phase3

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

Sponsor: UCB Biopharma SRL

NCT ID: NCT06055959

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zilucoplan (drug)
How long the study runs
Study runs about 26 months (dates as stated)
About the drug or intervention
Zilucoplan — drug: Zilucoplan will be administered subcutaneously to pediatric study participants.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years to 17 Years
Who
All
Number of participants
8
Started
2024-10-16
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for generalized myasthenia gravis
  • • Phase2/Phase3 - 8 participants
  • • 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 take part?

  • • Ages 12 Years to 17 Years
  • • Diagnosed with generalized myasthenia gravis

Where?

  • • Glasgow - Mg0014 40735
  • • London - Mg0014 40736

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Generalized Myasthenia Gravis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 17 Years
  • Who can join: All genders

Biomarkers mentioned

prior positiveknown positive

What 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 agreement to take part/assent according to local...
  • ✓Rest of world (ROW) specific inclusion criterion:
  • ✓\- Participant must be 2 to \<18 years of age at the time of signing the agreement to take part/assent according to local...
  • ✓Global inclusion criteria:

Who cannot take part

  • ✗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...
  • ✗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...
See the full criteria
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

Where Is This Study? (2 UK sites)

Mg0014 40735

Glasgow, United Kingdom

Recruiting

Mg0014 40736

London, United Kingdom

Recruiting

How to Get in Touch

UCB Cares

Sponsor contact

CONTACT

+18445992273 (USA) ucbcares@ucb.com

UCB Cares

Sponsor contact

CONTACT

001 844 599 2273
Data sourced from ClinicalTrials.gov · Last verified: 2026-09