Efgartigimod for hospitalized myasthenia gravis exacerbations or crisis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Hospitalized adults with AChR‑positive generalized myasthenia gravis who meet severity thresholds (for example QMG ≥11 or MG‑ADL ≥6) are enrolled within 24 hours of admission to receive efgartigimod. Researchers will track clinical recovery using validated scales such as the Quantitative Myasthenia Gravis (QMG) score and MG‑ADL, and will measure blood markers including circulating IgG and AChR antibody levels. The rationale is that efgartigimod reduces IgG similarly to plasma exchange, so it may speed symptom improvement without invasive apheresis. The work is conducted at the University of Colorado Aurora site in hospitalized patients and focuses on acute management rather than chronic outpatient dosing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. Documented positive response to cholinesterase inhibitors such as pyridostigmine or edrophonium
  2. Abnormal decrement on slow repetitive nerve stimulation testing
  3. Abnormal single fiber EMG
* Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:

  1. Quantitative Myasthenia Gravis (QMG) scale ≥ 11
  2. MG-ADL score ≥ 6
  3. Worsening weakness that is unlikely to be ameliorated by adjustment of current medications including impaired respiratory status, dysarthria, dysphagia, difficulty chewing, limb weakness, diplopia, ptosis.
* 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 Criteria:

* 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.

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Thomas Ragole, MD — University of Colorado, Denver
• Study coordinator: Alyssa Avilez, BS
• Email: alyssa.avilez@cuanschutz.edu
• Phone: 303.724.3522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.