CompletedPhase 3

Study of Telitacicept in Generalized Myasthenia Gravis

China114 participantsStarted 2023-03-28

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Patients with autoimmune diseases other than MG;
✕. Abnormal laboratory results；
✕. 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;
✕. 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;

Change from baseline in MG-ADL

Timeframe: Week 24

NCT IDNCT05737160

SponsorRemeGen Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-26