Actively Recruiting
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
Led by University of Colorado, Denver · Updated on 2025-07-11
20
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
argenx
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older with known generalized myasthenia gravis confirmed by positive acetylcholine receptor antibodies
- Positive response to cholinesterase inhibitors or abnormal nerve/muscle testing
- Evidence of worsening weakness requiring hospital admission with QMG score of 11 or higher or MG-ADL score of 6 or higher
- Worsening weakness unlikely to improve with medication changes, including impaired breathing, speech, swallowing, chewing, limb weakness, double vision, or eyelid drooping
- Ability to sign consent and enroll within 24 hours of hospital admission
You will not qualify if you...
- MG worsening related to active infection or certain medications
- Intubation before consent or within 24 hours of hospitalization
- Use of IVIG within 2 weeks or plasma exchange or efgartigimod within 4 weeks prior to admission
- Current use of C5-complement inhibitors like ravulizumab or eculizumab
- Other medical conditions affecting muscle strength or assessment validity
- History of blood clotting disorders or recent severe bleeding
- Pregnancy or breastfeeding
- IgG levels below 600 mg/dL
- Active or untreated hepatitis B or C infections, or HIV with low CD4 count
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Alyssa Avilez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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