A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Rozanolixizumab; Placebo
Intervention description: Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.; Subjects will receive placebo at pre-specified time points.
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: UCB7665; generalized myasthenia gravis; rozanolixizumab; gMG

Summary:

      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).
    

Eligibility criteria:

        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