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+SOCInitiate efgartigimod combined with standard of care (SOC) therapy according to the protocol within one month after consolidation baseline.
- Arm: SOCNo 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
- Yu wei Da, M.D.00-86-010-83198493
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