A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety
 and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
Inclusion Criteria:

 -  Study participant must be ≥18 years of age, at the time of signing the informed
 consent

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

 -  Study participant has a confirmed positive record of autoantibodies against
 acetylcholine 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 IVa
 at Visit 1

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

 -  Study participant is considered for additional treatment such as intravenous
 immunoglobulin 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 6 weeks prior
 to the first dose of investigational medicinal product (IMP)

 -  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) will be excluded

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

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

 -  Study participant has a history of a solid organ transplant or hematopoietic stem
 cell/marrow transplant