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Efgartigimod for Myasthenia Gravis Exacerbation or Crisis

This study is looking into whether the drug efgartigimod can help people experiencing a myasthenia gravis (MG) exacerbation or crisis, which is a sudden worsening of MG symptoms requiring hospital care. Efgartigimod is already approved for ongoing MG treatment in adults with specific antibodies (AChR antibodies), but its use during a crisis hasn't been studied. Researchers want to see if giving efgartigimod as an intravenous (IV) infusion on specific days improves symptoms and recovery. You might be able to join if you are an adult (18 or older) with generalized MG, have AChR antibodies, and meet other criteria like a positive response to certain MG medications. The study will measure success by looking at changes in your Myasthenia Gravis (QMG) score by day 11. This study is currently recruiting about 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll about 20 participants.
What's involved
You would receive efgartigimod as an IV infusion on days 1, 4, 11, and 18. Your QMG score will be measured at the start and on day 11.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at day 11, indicating follow-up at least to this point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06860633

Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Colorado, Denver
~20 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:Efgartigimod

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11
Measured over Baseline, Day 11

Conditions

Myasthenia Gravis Crisis
Myasthenia Gravis Exacerbations
AChR Myasthenia Gravis

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Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Thomas Ragole, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Alyssa Avilez, BS
[email protected]
303.724.3522
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults ≥ age 18 years with known generalized MG as identified by characteristic signs of generalized MG on clinical assessment and positive serology for AchR antibodies as well as one of the following:
Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:
Ability to sign consent and be enrolled within 24 hours of hospital admission. For participants transferred to University of Colorado Hospital, the time of admission/presentation to the outside hospital is counted towards this 24-hour cap.

Exclusion

MG worsening thought to be related to active infection or due to medications (e.g. fluoroquinolone or aminoglycoside antibiotics, magnesium, chloroquine derivatives)
Intubation prior to ability to sign informed consent or intubation within 24 hours of hospitalization
Use of IVIG within 2 weeks, or having undergone plasma exchange or received efgartigimod in the 4 weeks prior to admission
Current ongoing use of ravulizumab or eculizumab (monoclonal antibody C5-complement inhibitors).
Other medical conditions that, in the opinion of the investigator and treating clinicians, might interfere with the validity of assessment measures used in the study (e.g. steroid myopathy, CNS pathology, severe arthritis, fractures, etc.). This criterion is a standard exclusion in MG trials and relates solely to other conditions that reduce muscle power or range of motion and would thus worsen scores on assessment measures like the QMG due to non-MG conditions.
Known history of coagulopathy, blood clotting, recent severe bleeding (e.g. GI bleed).
Pregnancy or breastfeeding. Pregnancy must be excluded for all potential participants who are able to become pregnant prior to initiation of treatment.
IgG levels \< 600mg/dL
Evidence of active or chronic Hepatitis B infection, untreated Hepatitis C infection, HIV with low CD4 (\<200) count.

What this trial measures

  • Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11Baseline, Day 11

    The Quantitative Myasthenia Gravis (QMG) is a scoring system that quantifies disease severity by measuring ocular, bulbar, respiratory and limb strength. The total scores range from 0 to 39, with higher scores indicating greater disease severity.