Phase
Condition
Myasthenia Gravis Generalised
Sarcopenia
Polymyositis (Inflammatory Muscle Disease)
Treatment
rozanolixizumab
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participant must be ≥2 to <18 years of age inclusive, at the time of signingthe informed consent/assent according to local regulation
Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) at Screening that includes a record confirming the presence of MG specificautoantibodies to acetylcholine receptor (AChR) or muscle-specific kinase (MuSK)prior to Screening
Study participant has Myasthenia Gravis Foundation of America (MGFA) ClinicalClassification II to IVa at Screening
Study participant has received existing conventional treatment(s) for gMG (eg,pyridostigmine, corticosteroids, and/or immune suppressants) prior to Screening
Study participant has had an unsatisfactory clinical response or worsening of gMGsymptoms and is in need of additional therapy (for example, plasma exchange (PEX) ortreatment with intravenous immunoglobulin (IVIg))
Exclusion
Exclusion Criteria:
Study participant with severe weakness affecting oropharyngeal or respiratorymuscles, or who has myasthenic crisis or impending crisis at Screening or Baseline
Study participant has a known hypersensitivity to any components of theInvestigational Medicinal Product (IMP) or other anti-neonatal-Fc receptor (FcRn)medications
Study participant with any active or untreated thymoma
Study participant has a history of thymectomy within 6 months prior to Screening
Study participant has a clinically relevant active infection (eg, sepsis, pneumonia,or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6weeks prior to the first dose of IMP
Study participant has received a live vaccination within 4 weeks prior to Baselineor intends to have a live vaccination during the course of the study
Study Design
Connect with a study center
Mg0006 40290
Bologna,
ItalyActive - Recruiting
Mg0006 40144
Milano,
ItalyActive - Recruiting
Mg0006 40734
Lodz,
PolandActive - Recruiting
Mg0006 40155
Warszawa,
PolandActive - Recruiting
Mg0006 20081
Taipei City,
TaiwanActive - Recruiting
Mg0006 20095
Taipei City,
TaiwanActive - Recruiting
Mg0006 50574
Denton, Texas 76208
United StatesSite Not Available
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