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NCT06827587

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

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

Summary

Title: The Efficacy, Safety, and PK/PD of Efgartigimod Followed by Telitacicept in Generalized Myasthenia Gravis: Protocol of a Randomized Controlled Trial Objective: This study aims to evaluate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of efgartigimod followed by telitacicept in patients with generalized myasthenia gravis (gMG). Specifically, the trial seeks to determine the optimal treatment strategy for gMG by assessing the effect of sequential biologic therapy on disease management. Study Design: This is a multi-center, open-label, randomized controlled trial involving 60 acetylcholine receptor antibody-positive gMG patients.

Official title: Efficacy, Safety, and PKPD Study of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis (gMG): an Open-label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02

Completion Date

2026-12

Last Updated

2025-02-14

Healthy Volunteers

Conditions

Myasthenia Gravis Autoimmune Diseases Neuromuscular Diseases

Interventions

DRUG

Efgartigimod + Telitacicept (1-week interval) group

Drug 1: Efgartigimod Generic Name: Efgartigimod Formulation: Injection (Intravenous) Dose: 10 mg/kg Frequency: Once a week Route of Administration: Intravenous infusion Duration: 4 weeks (Week 0 to Week 4) Drug 2: Telitacicept Generic Name: Telitacicept Formulation: Injection (Subcutaneous) Dose: 240 mg Frequency: Once a week Route of Administration: Subcutaneous injection Duration: 25 weeks (Week 5 to Week 29)

DRUG

Efgartigimod + Telitacicept (2-week interval) group

DRUG

Telitacicept-only group

Drug: Telitacicept Generic Name: Telitacicept Formulation: Injection (Subcutaneous) Dose: 240 mg Frequency: Once a week Route of Administration: Subcutaneous injection Duration: 30 weeks (Week 0 to Week 29)

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).

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria