New hope for myasthenia crisis: early ravulizumab may speed ICU recovery
NCT ID NCT07411963
First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This study looks at whether giving the drug ravulizumab early, right after standard crisis treatments like plasma exchange or IVIg, can help people with severe myasthenia gravis recover faster in the ICU. About 30 adults with a specific antibody type will be followed for 6 months. The goal is to see if this approach shortens time on a ventilator, reduces hospital stay, and improves muscle strength.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ravulizumab (Ultomiris)
- What this could lead to
- If early ravulizumab helps patients recover faster from a myasthenic crisis, it could shorten ICU stays and reduce complications, improving care for this rare condition.
- What could go wrong
- This is a small observational study (30 patients) with no control group, so results may not prove cause and effect. Ravulizumab is already approved for maintenance, but its early use in crisis is not yet validated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with myasthenia gravis
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female aged ≥18 years. * Diagnosed with gMG with confirmed documentation and supported by a physical exam and confirmed seropositivity for AChR-Abs. * Patients having received more than 1 cycle of PLEX or IVIg 1-2 g/kg (max 50g/day), according to clinical practice. * Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class V - IV, at ICU admission. * Patients treated with at least one standard MG-targeted therapy. * Patients receiving Ravulizumab following PLEX of IVIg during their stay in the ICU, as per local label and reimbursement conditions. The prescription must be validated by experts from the French Health Care Network for rare neuromuscular diseases FILNEMUS. * Patients capable of understanding written informed consent and providing signed, dated, and witnessed written informed consent. If unable to sign the consent due to muscular weakness, a dedicated informed consent can be signed by a trusted witness. * Patients willing and able to comply with scheduled visits, treatment plan, study restrictions and other study procedures. * Patients affiliated to a European social security system. * Patients agree to comply with the prevention of meningococcal infections by vaccination and/or antibiotic prophylaxis in accordance with the current local vaccination/antibiotic prophylaxis recommendations. * Patients with no contraindication to anti-C5 treatment. * Patients with no contraindication to antibiotic therapy. Exclusion Criteria: * Active infection or other disorders causing weakness, known immunoglobulin A deficiency, active renal or hepatic disease, clinically significant cardiac disease, known hyperviscosity, or hypercoagulable state. * Any active malignancy. * Presence of antibodies other than anti-AChR-Ab+ (anti-titin-Ab+ were permitted as these are considered complementary markers to anti-AChR-Ab+). * Patient with a diagnosed thymoma. * Patient with a pathology judged by the investigator to interfere with the proper conduct of the study. * Positive pregnancy test. A urine pregnancy test will be carried out for women of childbearing age. * Any current mental condition (psychiatric disorder, senility, or dementia) that, in the opinion of the investigator, may affect study compliance or prevent understanding of the aims, investigational procedures, or possible consequences of the study. * Vaccination with live or live-attenuated vaccines within the 6 weeks. * Refusal of the subject to participate in the study. * Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code. * Known hypersensitivity to the active substance or to any of the excipients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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APHP
RECRUITINGLe Kremlin-Bicêtre, 94275, France
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CHU Pierre Paul Riquet
NOT_YET_RECRUITINGToulouse, 31059, France
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CHU de Lille
RECRUITINGLille, 59037, France
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CHU de NICE
RECRUITINGNice, Alpes-maritimes, 06000, France
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CHu de la Timone
RECRUITINGMarseille, 13385, France
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Hospices Civils de Lyon
NOT_YET_RECRUITINGBron, 69500, France
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Hôpital Raymond Pointcarré
NOT_YET_RECRUITINGGarches, 92380, France
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Hôpitaux universitaires de Strasbourg
RECRUITINGStrasbourg, 67200, France
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