Ensayos clínicos

Inclusion Criteria:

• Study participant must meet one of the following:
  • completed MG0003 or MGC003.
  • required resuce therapy (except IVIg or PEX) during the Observation Period in MG0003.
  • completed at lesat 6 visits in MG0004.
• Body weight of equal to or greater than 35kg at Baseline.
• Study participant may be male or female:
  • Males must agree to use contraception as detailed in Appendix 4 of this protocol duirng the treatment period and for at least 90 days after the last does of study treatment and refrain from donating sperm during this periol.
  • Females must not be pregnant, breastfeed and at least one of the following conditions applies:
    • Not a woman of childbearing potential (WOCBP) as defined in Appendix 4.
    • A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 90 days after hte last does of study treatment at Baseline (Day1) or each treatment cycle.
• Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent fomr (ICF) and in this protocol.
• Study participant is considered reliable and capable of adhering to the protocol visit schedule, or medication intake according to the judgment of the Investigator.

Exclusion Criteria:

• Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.
• Study participant has a history of alcohol use disorder or other substance use disorder (as per Diagnostic and Statistical Manual of Mental Disorders-5 [American Psychiatric Association, 2013]) within the previous 12 months.
• Study participant has a known hypersensitivity to any components of the study medication.
• 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.
• Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, MGC003, or MG0004, or permanently discontinued study drug in either study. 
• Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab.
• Study participant has absolute neutrophil count <1500 cells/mm3.
• Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis.
• Study 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 has renal impairment, defined as GFR less than 45mL/min/1.73m2.
• Study participant has 12-lead ECG with findings considered to be clinically significant upon medical review. The clinical significance of the findings needs to be assessed by the Investigator to determine eligibility, and any queries regarding continuation of the study participants will have to be addressed with the Medical Monitor.
• Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) are >3.0x upper limit of normal (ULN).
• Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin ULN ALT, AST, or ALP that does not meet the exclusion limit at Baseline (Day 1), repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the participant must be discussed with the Medical Monitor (tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation). This includes rescreening. Current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • NOTE: Stable chronic hepatobiliary disease (including Gilbert’s syndrome, and asymptomatic gallstones) is acceptable of the study participant otherwise meets entry criteria.
• Study participant has corrected QT interval (QTc) >450msec (for male participants) or QTc >470msec (for female participants) or QTc >480msec in participants with bundle branch block.
• A female study participant, who plans to get pregnant during the participation in the study.