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

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.

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 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: 24 weeks (Week 6 to Week 29)

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)

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital of Wenzhou Medical University

  lead OTHER

Principal Investigators

• Xu Zhang, Bachelor · First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-28

Primary Completion

2026-02-28

Completion

2026-12-31