Efgartigimod for Consolidation Therapy in gMG

Sponsor
Da, Yuwei, M.D.
Study ID
NCT07079020
Status
Not Yet Recruiting

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Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to evaluate the efficacy and safety of consolidation therapy with corticosteroids and/or immunosuppressants combined with efgartigimod in patients with generalized myasthenia gravis after the acute exacerbation.

Key Dates

First listed
Jul 22, 2025
Start date
Jul 30, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Efgartigimod+SOC
    Initiate efgartigimod combined with standard of care (SOC) therapy according to the protocol within one month after consolidation baseline.
  • Arm: SOC
    No additional treatments are to be administered other than the standard of care (SOC) therapy.

Primary Outcome Measure

Proportion of patients achieving and maintaining minimal symptom expression (MSE) for at least 4 months after first attaining MSE status at any time during the consolidation therapy period within 2 months. [ Time Frame: Consolidation baseline up to Month 6 ]

Central Contacts

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