NCT06587867

Seronegative Myasthenia Gravis - Efgartigimod IV

Efficacy, Safety and Tolerability of Efgartigimod in Patients with Seronegative Generalized Myasthenia Gravis: an Open-Label Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

There will be screening period that includes ECG, safety blood collection, collection of demographics, vital signs, questionnaires, weight, pregnancy test (if applicable), genetic test. If eligible, participants will have run-in period from week 2 to week 5. Baseline is at week 6. Induction phase will be weekly from week 7, 8, and 9. Maintenance phase will be once every 2 weeks thereafter. Observation period will have 4 visits, End of study is at week 43.

Conditions

• Efgartigimod
• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
BIOLOGICAL	efgartigimod	active drug efgartigimod to be administer

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study