A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Inclusion Criteria:

• Study participant must be ≥18 years of age, at the time of signing the informedconsent

• Study participant has documented diagnosis of generalized myasthenia gravis (gMG) atVisit 1, based on study participant's history and supported by previous evaluations

• Study participant has a confirmed positive record of autoantibodies againstacetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1

• Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVaat Visit 1

• Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) scoreof at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myastheniagravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)

• Study participant is considered for additional treatment such as intravenousimmunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator

Exclusion Criteria:

• Study participant has a known history of hyperprolinemia

• 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 investigational medicinal product (IMP)

• 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) will be excluded

• Study participant has experienced hypersensitivity reaction after exposure to otheranti-neonatal Fc receptor (FcRn) drugs

• Study participant with severe (defined as Grade 3 on the MyastheniaGravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngealor respiratory muscles, or who has myasthenic crisis or impending crisis at Visit 1or Visit 2

• Study participant has a history of a solid organ transplant or hematopoietic stemcell/marrow transplant