New drug may help elderly MG patients ditch harmful steroids
NCT ID NCT07072988
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 4 times
Summary
This study looks at whether efgartigimod, a drug that lowers harmful antibodies, can help elderly patients with generalized myasthenia gravis reduce their steroid use. Steroids often cause serious side effects in older adults. The study will follow 50 patients for 12 months to see if switching to efgartigimod improves muscle strength, quality of life, and overall health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- efgartigimod
- What this could lead to
- If successful, this could show that efgartigimod helps elderly MG patients reduce their steroid dose, leading to fewer side effects and better quality of life.
- What could go wrong
- This is a small, early-phase study with only 50 participants, so results may not apply to all patients. Efgartigimod may not work as well in real-world settings as in controlled trials.
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.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Oct 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.
- Ages
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65 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 subjects aged ≥65 years * Diagnosed with gMG with confirmed documentation and supported by a physical exam and confirmed seropositivity for AChR-Abs. * Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class IIa, Iib, IIIa, IIIb. * Patient suitable for efgartigimod treatment * MG-ADL score ≥ 2 * Treated with high (\>50mg/daily) or intermediate (20-50mg/daily) dose of oral corticosteroids (prednisone or prednisolone) and in stable dose of concomitant treatments for at least three months (changes of anticholinesterase therapy are permitted). * Patient that has developed at least one of the following iatrogenic comorbidities after the introduction of intermediate or high dose of oral corticosteroids: type 2 diabetes; arterial hypertension; overweight; sleep disorders; irritability and/or Patient experiencing a documented worsening of at least one of the following comorbidities after the introduction of intermediate or high dose of corticosteroids, including type 2 diabetes; arterial hypertension; overweight; sleep disorders; irritability * Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent * Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures * Patient affiliated to a European social security system Exclusion Criteria: * 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; and/or patient with a Mini-mental State Examination (MMSE) \<28. * History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. * Ongoing malignancy including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured) * Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening * Vaccination with live or live-attenuated vaccines within the 6 weeks * Patient already treated with anti-complement (wash-out period 3 months) or anti-FcRN (wash-out period 3 months), anti-CD20 (wash-out period 6 months) and PLEX (wash-out period 1 month) * Patient with end-stage disease or with a disease that will enable him to be evaluated and/or treated * 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.
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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
9 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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CHRU de Nancy
RECRUITINGNancy, 54000, France
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CHU Charles Nicolle
RECRUITINGRouen, 76031, France
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CHU de Grenoble
RECRUITINGGrenoble, 38700, France
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CHU de Nice
RECRUITINGNice, Alpes-Maritimes, 06000, France
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CHU de Toulouse
RECRUITINGToulouse, 31059, France
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CHU de la Timone
RECRUITINGMarseille, 13385, France
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Hôpital Henri Mondor
RECRUITINGCréteil, 94000, France
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Hôpital Raymond Pointcarré
NOT_YET_RECRUITINGGarches, 92380, France
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Hôpital Roger Salengro
RECRUITINGLille, 59037, France
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