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New treatment option for Myasthenia Gravis Crisis
Official title Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
ClinicalTrials.gov ID: NCT06860633
What this study is testing
What is Efgartigimod?
Efgartigimod is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis crisis.
Also referred to as Vyvgart.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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").
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥ age 18 years with known generalized MG as identified by characteristic signs of generalized MG on clinical assessment and positive serology...
- Documented positive response to cholinesterase inhibitors such as pyridostigmine or edrophonium
- Abnormal decrement on slow repetitive nerve stimulation testing
- Abnormal single fiber EMG
- Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:
You likely can't join if
- MG worsening thought to be related to active infection or due to medications (e.g. fluoroquinolone or aminoglycoside antibiotics, magnesium...
- 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...
- Known history of coagulopathy, blood clotting, recent severe bleeding (e.g. GI bleed).
See the full eligibility 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:
- Documented positive response to cholinesterase inhibitors such as pyridostigmine or edrophonium
- Abnormal decrement on slow repetitive nerve stimulation testing
- Abnormal single fiber EMG
- Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:
- Quantitative Myasthenia Gravis (QMG) scale ≥ 11
- MG-ADL score ≥ 6
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.