Not Yet RecruitingNot Applicable

Efgartigimod for Consolidation Therapy in gMG

130 participantsStarted 2025-07-30

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years, male or female.
✓. Diagnosis of myasthenia gravis (MG) based on the following:
✓. Typical clinical features of MG.
✓. At least one of the following:
✓. MGFA classification II-IV at consolidation baseline.
✓. Seropositive for anti-AChR antibodies (required for enrollment).
✓. Hospitalized for myasthenic crisis (MC) in the acute exacerbation and completed one treatment cycle of efgartigimod: acute exacerbation definition: Presence of MC warning signs (new or worsening within 2 weeks): Bulbar symptoms: Dysphagia, choking, weak cough, dysarthria. Respiratory symptoms: Dyspnea, respiratory muscle weakness. Generalized weakness: Head drop, jaw weakness, facial weakness. One treatment cycle of efgartigimod: 10 mg/kg IV, once weekly for 4 doses.
✓. ≥2-point improvement in MG-ADL score from acute exacerbation baseline by Day 4 of efgartigimod treatment.

Exclusion criteria

✕. Treatment with IVIg, plasma exchange (PE), IV methylprednisolone (IVMP), or immunoadsorption (IA) within 1 month before consolidation baseline.
✕. Thymectomy within 6 months before exacerbation baseline.
✕. Use of immunomodulatory monoclonal antibodies or investigational drugs (not listed above) within 3 months before baseline or 5 half-lives (whichever is longer).
✕. Pregnancy or lactation (women of childbearing potential must have negative pregnancy test and use contraception).
✕. Known hypersensitivity to efgartigimod or any FcRn-targeting therapy.
✕. Clinically significant comorbidities, including severe cardiovascular, hepatic, renal, pulmonary, or hematologic disorders, active malignancy and uncontrolled systemic infections.
✕. Other autoimmune diseases that may interfere with efficacy assessment (e.g., uncontrolled thyroid disease, severe rheumatoid arthritis).
✕. Any other condition deemed unsuitable by the investigator.

What they're measuring

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.

Timeframe: Consolidation baseline up to Month 6

Trial details

NCT IDNCT07079020

SponsorDa, Yuwei, M.D.

Sponsor typeINDIV

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Yu wei Da, M.D.

00-86-010-83198493 dayuwei100@hotmail.com

View on ClinicalTrials.gov More Myasthenia Gravis trials