Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Treatment
Rozanolixizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participant must be ≥18 years of age at the time of signing the informedconsent form (ICF)
Study participant has documented diagnosis of generalized myasthenia gravis (gMG) atthe Screening Visit based on study participant's history and supported by previousevaluation
Study participant has a confirmed positive record of autoantibodies againstacetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in themedical history at the Screening Visit
Study participant has Myasthenia Gravis Foundation of America (MGFA) ClinicalClassification II to IV at Screening Visit.
Study participant with a myasthenia gravis-activities of daily living (MG-ADL) scoreof at least 3 points from non-ocular symptoms and a quantitative myasthenia gravis (QMG) score of at least 11 at the Screening and Baseline visits in the firstTreatment Cycle.
Study participant is considered for additional treatment by the investigator
Body weight ≥35kg at the Screening Visit
Exclusion
Exclusion Criteria:
Study participant has a known hypersensitivity to any components of the study drugor any other anti-neonatal Fc receptor (anti-FcRn) medications
Study participant has a clinically important active infection including unresolvedor not adequately treated infection in the opinion of the investigator
Study participant with a known tuberculosis (TB) infection, at high risk ofacquiring TB infection, or latent tuberculosis infection (LTBI), or current/historyof nontuberculous mycobacterial infection (NTMBI)
Study participant has previously received rozanolixizumab drug product
Study participant has received any vaccine in the 4 weeks prior to the initiation ofrozanolixizumab treatment or intends to receive any vaccine within 2 weeks after thelast infusion of rozanolixizumab. Note: For participants that are on rozanolixizumabtreatment, vaccination with live or live-attenuated vaccines is not recommended.During the whole study period, all other vaccines should take place at least 2 weeksafter the last infusion of a Treatment Cycle and 4 weeks before initiating the nextcycle
Study participant has been treated with prohibited immunosuppressants, biologics,and other therapies within the timeframe shorter than the treatment-free period
Study participant with severe (defined as Grade 3 on the MG-ADL scale) weaknessaffecting oropharyngeal or respiratory muscles, or who has myasthenic crisis orimpending crisis. Note: Impending Crisis is defined as bulbar or respiratorysymptoms of a patient who significantly worsens in a short time (≤2 weeks) and meetMGFA IVb or score 3 in one QMG bulbar muscle item, or score 2 in respiratory muscleitem, or bulbar+respiratory items score ≥4
Study Design
Connect with a study center
Mg0033 20040
Beijing,
ChinaActive - Recruiting
Mg0033 20261
Changchun,
ChinaActive - Recruiting
Mg0033 20295
Changsha,
ChinaActive - Recruiting
Mg0033 20295
Changsha 1815577,
ChinaSite Not Available
Mg0033 20348
Fuzhou,
ChinaActive - Recruiting
Mg0033 20348
Fuzhou 1810821,
ChinaSite Not Available
Mg0033 20269
Guangzhou,
ChinaActive - Recruiting
Mg0033 20185
Jinan,
ChinaActive - Recruiting
Mg0033 20347
Jinan,
ChinaActive - Recruiting
Mg0033 20185
Jinan 1805753,
ChinaActive - Recruiting
Mg0033 20347
Jinan 1805753,
ChinaSite Not Available
Mg0033 20172
Shanghai,
ChinaActive - Recruiting
Mg0033 20172
Shanghai 1796236,
ChinaSite Not Available
Mg0033 20184
Shenzhen,
ChinaActive - Recruiting
Mg0033 20184
Shenzhen 1795565,
ChinaSite Not Available
Mg0033 20204
Suzhou,
ChinaActive - Recruiting
Mg0033 20204
Suzhou 1886760,
ChinaSite Not Available
Mg0033 20180
Wuhan,
ChinaActive - Recruiting
Mg0033 20349
Xuzhou SHI,
ChinaActive - Recruiting

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