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RECRUITING
NCT06860633
PHASE4

Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as "exacerbation"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are: * Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization? * Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies? Participants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.

Official title: Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-03-06

Completion Date

2026-12-31

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

DRUG

Efgartigimod

Dose of 10 mg/kg for IV infusion on days 1, 4, 11 and 18

Locations (1)

University of Colorado

Aurora, Colorado, United States