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

Recruiting now · Phase 2/Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

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).

Key facts

Study ID

NCT06055959

Run by

UCB Biopharma SRL

People needed

8

Starts

2024-10-16

Expected to finish

2026-12-25

Last updated by the study team

2026-07-31

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Mg0014 40774 — Katowice, Poland (enrolling)
• Mg0014 20220 — Seoul, South Korea (enrolling)
• Mg0014 40735 — Glasgow, United Kingdom (enrolling)
• Mg0014 40736 — London, United Kingdom (enrolling)
• Mg0014 40144 — Milan, Italy (enrolling)
• Mg0014 40218 — Warsaw, Poland
• Mg0014 50574 — Flower Mound, Texas, United States
• Mg0014 50168 — Chicago, Illinois, United States
• Mg0014 20104 — Seoul, South Korea

Full record on ClinicalTrials.gov

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