Clinical Trials

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) prior to Visit 1.
• Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1.
• Study participant with a MG-ADL score of at least 3 (with ≥ 3 points from non-ocular symptom) AND a QMG score of at least 11 at Visit 1 and at Baseline (Visit 2).
• Study participant is considered for additional treatment such as IVIg or PEX by the Investigator.
• Body weight ≥ 35kg at Visit 1.
• Study participants may be male or female − A male study participant must agree to use contraception as detailed in Appendix 4 (Section 10.4) of this protocol during the Treatment Period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. − A female participant is eligible to participate if she is not pregnant (see Section 10.4), not breastfeeding, and at least one of the following conditions applies: ◦ Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 OR ◦ A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 during the Treatment Period and for at least 90 days after the last dose of study treatment. The study participant must have a negative serum pregnancy test at Visit 1, which is confirmed to be negative by urine testing prior to the first dose of study medication at Visit 2.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

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) within 12 months prior to Visit 1. 3.
• Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol.
• Study participant has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.
• Study participant has a clinically relevant active infection (e.g., 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 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 been previously received rozanolixizumab drug product.
• Study participant has received a live vaccination within 8 weeks prior to Visit 2; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of IMP.
• Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies within timeframe shorter than no-treatment period.
• Study participant has been treated with any biological agent in the past 3 months or within 5 half-lives prior to Visit 2, whichever was longer.
• Study participant has prior treatment with rituximab in the 6 months prior to Visit 2 or study participant has prior treatment with rituximab in the 12 months prior to Visit 2 and B cells monitoring have shown they did not return to normal range.
• Study participant had a thymectomy in the past 6 months or a thymoma at any time that required chemotherapy and/or radiotherapy prior to Visit 1.
• .Study participant has any of the following active GI disorders:
  • inflammatory bowel disease (IBD); or
  • GI ulceration or diverticulitis.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.