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
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What we know so far
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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
Mg0014 40736
London, United Kingdom
How to Get in Touch
UCB Cares
Sponsor contactCONTACT
+18445992273 (USA) ucbcares@ucb.com
UCB Cares
Sponsor contactCONTACT
001 844 599 2273
Data sourced from ClinicalTrials.gov · Last verified: 2026-09
