New drug may help elderly MG patients ditch harmful steroids

NCT ID NCT07072988

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

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

Started

Sep 2025

Expected to finish

Oct 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.

Ages

65 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 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Myasthenia gravis, generalized are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

    9 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

  • CHRU de Nancy

    RECRUITING

    Nancy, 54000, France

  • CHU Charles Nicolle

    RECRUITING

    Rouen, 76031, France

  • CHU de Grenoble

    RECRUITING

    Grenoble, 38700, France

  • CHU de Nice

    RECRUITING

    Nice, Alpes-Maritimes, 06000, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • CHU de la Timone

    RECRUITING

    Marseille, 13385, France

  • Hôpital Henri Mondor

    RECRUITING

    Créteil, 94000, France

  • Hôpital Raymond Pointcarré

    NOT_YET_RECRUITING

    Garches, 92380, France

  • Hôpital Roger Salengro

    RECRUITING

    Lille, 59037, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.