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

Sponsor
First Affiliated Hospital of Wenzhou Medical University
Study ID
NCT06827587
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Diseases
  • Myasthenia Gravis
  • Neuromuscular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod + Telitacicept (1-week interval) group — DRUG
    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)
  • Efgartigimod + Telitacicept (2-week interval) group — DRUG
    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)
  • Telitacicept-only group — DRUG
    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)

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Feb 28, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod + Telitacicept (1-week interval) group
    Starting from Week 0, participants will receive efgartigimod (10 mg/kg) for induction treatment by intravenous infusion over 1 hour, administered once a week for 4 consecutive weeks. After a 1-week interval, at Week 5, participants will receive telitacicept (240 mg) for maintenance treatment, administered once a week by subcutaneous injection for a total of 25 weeks. Follow-up will continue until Week 30.
  • Experimental: Efgartigimod + Telitacicept (2-week interval) group
    Starting from Week 0, participants will receive efgartigimod (10 mg/kg) for induction treatment by intravenous infusion over 1 hour, administered once a week for 4 consecutive weeks. After a 2-week interval, at Week 6, participants will receive telitacicept (240 mg) for maintenance treatment, administered once a week by subcutaneous injection for a total of 24 weeks. Follow-up will continue until Week 30.
  • Active Comparator: Telitacicept-only group
    Participants will not receive efgartigimod for induction treatment. Starting from Week 0, participants will receive telitacicept (240 mg) for maintenance treatment, administered once a week by subcutaneous injection for a total of 30 weeks. Follow-up will continue until Week 30.

Primary Outcome Measure

Change from baseline in QMG score [ Time Frame: 30 weeks after randomization ]

Central Contacts

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