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New hope for myasthenia crisis: early ravulizumab may speed ICU recovery

NCT ID NCT07411963

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • APHP

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • CHU Pierre Paul Riquet

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • CHU de Lille

    RECRUITING

    Lille, 59037, France

  • CHU de NICE

    RECRUITING

    Nice, Alpes-maritimes, 06000, France

  • CHu de la Timone

    RECRUITING

    Marseille, 13385, France

  • Hospices Civils de Lyon

    NOT_YET_RECRUITING

    Bron, 69500, France

  • Hôpital Raymond Pointcarré

    NOT_YET_RECRUITING

    Garches, 92380, France

  • Hôpitaux universitaires de Strasbourg

    RECRUITING

    Strasbourg, 67200, France

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