Seronegative Myasthenia Gravis - Efgartigimod IV

Sponsor
University Health Network, Toronto
Study ID
NCT06587867
Phase
PHASE3
Status
Recruiting
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Conditions

  • Efgartigimod
  • Generalized Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • efgartigimod — BIOLOGICAL
    active drug efgartigimod to be administer

Study Details

This is to study the efficacy, safety and tolerability of efgartigimod in patients with seronegative generalized myasthenia gravis. This is an open label study. There will be 30 participants to enroll at University Health Network Toronto General Hospital. Study duration is 43 weeks from screening to end of study.

Key Dates

Start date
Jun 1, 2023
Status verified
Aug 2024
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

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

Arms

  • Other: efgartigimod
    active treatment with efgartigimod.

Primary Outcome Measure

Total Myasthenia Gravis Impairment Index (MGII) score [ Time Frame: through study completion for 42 weeks ]

Central Contacts

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