Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06860633
Phase
PHASE4
Status
Recruiting
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Conditions

  • AChR Myasthenia Gravis
  • Myasthenia Gravis Crisis
  • Myasthenia Gravis Exacerbations

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Efgartigimod
    Participants receive 4 doses of efgartigimod via intravenous (IV) infusion over the course of the study on days 1, 4, 11 and 18.

Primary Outcome Measure

Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11 [ Time Frame: Baseline, Day 11 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Alyssa Avilez, BS
[email protected]
303-724-3522
Thomas Ragole, MD (PRINCIPAL_INVESTIGATOR)
Aaron Carlson, MD (SUB_INVESTIGATOR)
Brian Sauer, MD, PhD (SUB_INVESTIGATOR)
Elizabeth Matthews, MD (SUB_INVESTIGATOR)

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By research site
University of Colorado· Aurora, CO

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