EFG vs IVIG in TAMG

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07231523
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Efgartigimod
  • Intravenous Immunoglobulin
  • Myasthenia Gravis Associated With Thymoma

Eligibility Criteria

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

Interventions

  • Efgartigimod + Thymectomy — COMBINATION_PRODUCT
    Patients receive weight-based EFG infusions (10 mg/kg; fixed 1200 mg for ≥120 kg) administered over 1 hour once weekly for 4 total doses. If a scheduled infusion is missed, EFG may be administered within 48 hours of the planned time, followed by resumption of the original schedule to complete all 4 infusions. Thymectomy is performed on the day following the second EFG infusion with a permitted ±3-day surgical window.
  • Intravenous immunglobulin + Thymectomy — COMBINATION_PRODUCT
    Patients receive weight-based IVIG infusions (400 mg/kg) administered daily for 5 consecutive days. Thymectomy is performed approximately 7 days after completing the final IVIG infusion, with a permitted ±3-day surgical window.

Study Details

This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.

Key Dates

Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: Efgartigimod + Thymectomy
  • Active Comparator: Intravenous immunglobulin + Thymectomy

Primary Outcome Measure

Quantitative Myasthenia Gravis (QMG) reduction [ Time Frame: From baseline to 2 weeks postoperatively ]

Central Contacts

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