Study of Telitacicept in Generalized Myasthenia Gravis

Korábbi kezelés

• Use of immunosuppressants other than standard therapy within 1 month before randomization;
• Use of biologic agents targeting therapy, such as Rituximab or complement C5 inhibitors, within 6 months before randomization;
• Use of neonatal Fc receptor (FcRn) antagonists, intravenous immunoglobulin (IVIg), or plasmapheresis within 2 months before randomization;
• Patients currently suffering from thymoma-associated immunodeficiency syndrome (Good's syndrome) or who underwent thymectomy within 6 months before screening;
• Received or plan to receive any live vaccine within 3 months prior to randomization;
• Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);

Más betegség

• Patients with autoimmune diseases other than MG;
• Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the study;
• Acute or chronic infection requiring treatment;
• Current active hepatitis;
• HIV antibody positive;
• Patients with malignant tumors;
• Allergy to biological products of human origin;
• Patients considered unsuitable by the investigator to participate in the trial (e.g., patients with severe mental disorders);
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Laborértékek

• Abnormal laboratory results；

Egyéb

• Pregnant or lactating women, and those intending to become pregnant during the trial;

• Written informed consent provided;
• Male or female patients aged 18-80 years;
• Diagnosis with generalized myasthenia gravis;
• MGFA Class II, III, or IVa;
• AChR-Ab or MuSK-Ab positive;
• A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms;
• QMG ≥ 8, with ≥ 4 items score at least 2;
• Have been on a stable MG SoC regimen.