drugset / Trial / NCT06827587
Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis
Not yet recruiting
60 enrolled
First Affiliated Hospital of Wenzhou Medical University
Ningbo Medical Center Lihuili Hospital · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabSir Run Run Shaw Hospital · collabZhejiang Provincial People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-02
- Primary completion
- 2026-02
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | Telitacicept | Protein / enzyme biologic | 240 mg | Subcutaneous |