Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT06221501
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod Alfa — DRUG
    Efgartigimod will be administered intravenously on Day (D)1, D8, D15, and D22 at a dose of 10 mg/kg according to the patient's weight (maximum infusion dose of 1200 mg) over approximately 1 hour for a total of 4 doses. Thymectomy will be performed on Day 9.

Study Details

It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.

Key Dates

Start date
Feb 1, 2024
Status verified
Jan 2024
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Change of the activity of daily living (ADL) score at the fourth visit from the baseline visit (first visit) [ Time Frame: Baseline and 3 weeks after the first visit. ]

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