Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis

Launched by FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with generalized myasthenia gravis (gMG), a condition that affects the nerves and muscles, causing weakness. The trial is specifically looking at the effectiveness and safety of two medications, efgartigimod and telitacicept, used in sequence to help manage the symptoms of gMG. Researchers want to find out how well this combination works and how it affects the body’s response to the treatment.

To be eligible for the trial, participants must be adults aged 18 to 80 who have been diagnosed with gMG and have specific symptoms that fluctuate. They should have a positive test for certain antibodies linked to the disease. However, some individuals will not qualify, such as those with other active autoimmune diseases or severe infections, and those who have recently used certain treatments. Participants in the trial can expect regular check-ups and monitoring throughout the study to ensure their safety and track how well the treatment is working. This trial is not yet recruiting, but it aims to provide important insights into better treatment options for gMG patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient voluntarily signs the informed consent form.
• • Age ≥18 and ≤80 years, regardless of gender.
• • Meets the diagnostic criteria for Myasthenia Gravis (MG) as per the 2020 China MG Diagnosis and Treatment Guidelines, with serological evidence of positive AChR-Ab.
• • MG Clinical Classification according to the Myasthenia Gravis Foundation of America (MGFA) Staging System: Grade II-IV.
• • Patients with fluctuating MG symptoms before enrollment, as indicated by MG-ADL score ≥6 or Quantitative Myasthenia Gravis score (QMG) ≥8, maintained for more than 24 hours.
• Exclusion Criteria:
• • Coexisting active autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, Sjögren's Syndrome, etc.
• • Patients with active infections, such as Herpes Zoster, HIV, active Tuberculosis, active Hepatitis.
• • Patients with thymoma who have undergone surgery within the past 6 months.
• • Patients with malignancies other than thymoma.
• • Patients with severe liver or renal dysfunction, defined as: Liver function: ALT or AST \> 3 ×ULN (upper limit of normal). Renal function: Glomerular filtration rate (GFR) \< 30 mL/min/1.73m².
• • IgG ≤ 400 mg/dL.
• • Patients who have used biologic agents before enrollment and are within 5 half-lives of the drug, such as those who have used Telitacicept within the past 2 months, Efgartigimod within the past 1 month, or Rituximab within the past 6 months.
• • Patients who have received intravenous immunoglobulin (IVIg) or undergone plasmapheresis within the past 2 months before enrollment.
• • Patients who have received any live vaccines within 3 months before the study or plan to receive any vaccines during the study.
• • Pregnant or breastfeeding women, or those planning to conceive during the trial.
• • Patients with allergies to human-derived biologics.
• • Patients who have participated in any clinical trial within the 28 days before enrollment or are within 5 half-lives of the investigational drug used in a prior clinical trial.
• • Other patients deemed unsuitable for enrollment by the investigator (e.g., severe mental disorders).