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A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT06055959•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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
•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

Locations (9)

Mg0014 50168

Chicago, Illinois, United States

Mg0014 50574

Denton, Texas, United States

Mg0014 40144

Milan, Italy

Mg0014 40774

Katowice, Poland

Mg0014 40218

Warsaw, Poland

Mg0014 20104

Seoul, South Korea

Mg0014 20220

Seoul, South Korea

Mg0014 40735

Glasgow, United Kingdom

Mg0014 40736

London, United Kingdom

Key Dates

Start Date

October 16, 2024

Primary Completion Date

November 16, 2026

Completion Date

December 25, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Generalized Myasthenia Gravis

Interventions

Zilucoplan

DRUG

Contacts

UCB Cares

CONTACT

+18445992273 (USA)ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

NCT07247279

Rare DiseasesGeneralized Myasthenia Gravis (gMG)

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A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

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Generalized Myasthenia Gravis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

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Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis

Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis