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

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

December 31, 2026

Conditions
Myasthenia GravisAutoimmune DiseasesNeuromuscular 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)

All Listed Sponsors
collaborator

Zhejiang Provincial People's Hospital

OTHER

collaborator

Sir Run Run Shaw Hospital

OTHER

collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

lead

First Affiliated Hospital of Wenzhou Medical University

OTHER

NCT06827587 - Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis | Biotech Hunter | Biotech Hunter