A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
NCT ID: NCT06055959
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
8 participants
INTERVENTIONAL
2024-10-16
2026-12-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zilucoplan Arm
Study participants will receive zilucoplan in pre-defined dose based on their weight.
Zilucoplan
Zilucoplan will be administered subcutaneously to pediatric study participants.
Interventions
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Zilucoplan
Zilucoplan will be administered subcutaneously to pediatric study participants.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- 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 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
12 Years
17 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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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
Countries
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Central Contacts
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UCB Cares
Role: CONTACT
Other Identifiers
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U1111-1290-3349
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502072-23
Identifier Type: REGISTRY
Identifier Source: secondary_id
MG0014
Identifier Type: -
Identifier Source: org_study_id
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