Phase
Condition
Neuropathy
Myasthenia Gravis Generalised
Sarcopenia
Treatment
Zilucoplan
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 Informedconsent/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 Informedconsent/assent according to local regulation
Global inclusion criteria:
Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by aprior positive serologic test result to acetylcholine receptor (AChR) prior toScreening
Participant meets the criteria as defined by the Myasthenia Gravis Foundation ofAmerica (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 adolescentsfrom 12 years to <18 years of age at Screening
Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2years to <12 years of age at Screening (does not apply to US)
Documented vaccination against meningococcal infections within 3 years prior tostudy start. If not fully vaccinated, participants must receive appropriateprophylactic antibiotic treatment until at least 2 weeks after the initial dose ofvaccine(s)
Exclusion
Exclusion Criteria:
Participant has known positive serology for muscle-specific kinase
Participant has any medical or psychiatric condition that, in the opinion of theInvestigator, could jeopardize or would compromise the participant's ability toparticipate 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 judgementof the Investigator
Current or recent systemic infection within 2 weeks prior to Baseline or infectionrequiring intravenous antibiotics within 4 weeks prior to Baseline
Study Design
Connect with a study center
Mg0014 40144
Milano,
ItalyActive - Recruiting
Mg0014 20104
Seoul,
Korea, Republic ofActive - Recruiting
Mg0014 20220
Seoul,
Korea, Republic ofActive - Recruiting
Mg0014 40774
Katowice,
PolandActive - Recruiting
Mg0014 40218
Warszawa,
PolandActive - Recruiting
Mg0014 40735
Glasgow,
United KingdomActive - Recruiting
Mg0014 40736
London,
United KingdomActive - Recruiting
Mg0014 50168
Chicago, Illinois 60611
United StatesActive - Recruiting
Mg0014 50574
Denton, Texas 76208
United StatesActive - Recruiting
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