About this trial
The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.
Eligibility criteria
Qualifiers
Study participant must be ≥18 years of age at the time of signing the informed consent form (ICF)
Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at the Screening Visit based on study participant's history and supported by previous evaluation
Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in the medical history at the Screening Visit
Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening Visit.
Disqualifiers
Study participant has a known hypersensitivity to any components of the study drug or any other anti-neonatal Fc receptor (anti-FcRn) medications
Study participant has a clinically important active infection including unresolved or not adequately treated infection in the opinion of the investigator
Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
Study participant has previously received rozanolixizumab drug product
Trial design
Treatments tested in this trial
- Rozanolixizumab