A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Rozanolixizumab
Intervention description: Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: UCB7665; generalized myasthenia gravis; rozanolixizumab; gMG

Summary:

      The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and
      long-term efficacy of rozanolixizumab in study participants with generalized myasthenia
      gravis (MG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was eligible for MG0003 [NCT03971422] or MGC003 at the time of enrollment
             into either study and the participant either completed the observation Period of
             MG0003 or MGC003 or required rescue therapy during the Observation Period of the
             lead-in studies

          -  Body weight ≥35 kg at Visit 1

          -  Study participants may be male or female

        Exclusion Criteria:

          -  Evidence of active or latent tuberculosis (TB) as documented by medical history and
             examination, if applicable, chest X-rays (posterior anterior and lateral), and TB
             testing by a positive (not indeterminate) QuantiFERON®-TB Gold Plus

          -  Participant has received a live vaccination within 8 weeks prior to the Baseline
             visit; or intends to have a live vaccination during the course of the study or within
             8 weeks following the final dose of study medication

          -  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-activates of daily living (MG-ADL) scale) weakness
             affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or
             impending crisis

          -  Participant has any laboratory abnormality that, in the opinion of the Investigator,
             is clinically significant, has not resolved at randomization, and could jeopardize or
             compromise the study participant's ability to participate in this study

          -  Study participant met any mandatory withdrawal or mandatory study drug discontinuation
             criteria MG0003 [NCT03971422] or MGC003, or discontinued study medication in either
             study, with the exception of discontinuation due to a need for rescue treatment

          -  Study participant is not considered capable of adhering to the protocol visit
             schedule, or medication intake according to the judgment of the Investigator

          -  Study participant has a lifetime history of suicide attempt (including an active
             attempt, interrupted attempt, or aborted attempt), or had suicidal ideation since the
             last visit in MG0003 as indicated by a positive response (Yes) to either Question 4 or
             Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)