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Clinical trial Recruiting at 8 sites Phase 4 Interventional Ages 65 and up

Corticosteroid-sparing efgartigimod for elderly AChR-positive generalized myasthenia gravis

Official title: A Multicenter, Prospective, Observational, Open-label Study to Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod

Run by Centre Hospitalier Universitaire de Nice · NCT07072988 · Data updated 2026-11-12

This trial tests whether efgartigimod given IV or under the skin helps people 65 and older with AChR-positive generalized myasthenia gravis reduce their corticosteroid dose while keeping symptoms under control.

Quick facts

PhasePhase 4
Study typeInterventional
Ages65 Years and up
SexAll
Enrollment50 (estimated)
SponsorCentre Hospitalier Universitaire de Nice
Academic / other
Drugs / interventionsprednisone
Locations9 sites (Nice, Alpes-Maritimes and 8 other locations)
StatusRecruiting
StartedSeptember 19, 2025
Main results expectedOctober 1, 2027
Study endsOctober 1, 2027
Registry record updatedSeptember 3, 2026
Trial IDNCT07072988 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 65 or older with generalized, AChR-antibody positive myasthenia gravis (MGFA class II–III), MG-ADL ≥2, on a stable intermediate-to-high daily oral corticosteroid dose for at least three months and experiencing steroid-related comorbidities.

Probably not a fit

Patients who are seronegative or have only MuSK/LRP4 antibodies, are younger than 65, are not taking significant corticosteroids, or have unstable concomitant therapies are unlikely to benefit from this specific protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial enrolls patients aged 65 or older with generalized, AChR-antibody positive myasthenia gravis who are on stable intermediate-to-high doses of oral corticosteroids. Participants receive efgartigimod by IV or subcutaneous dosing with the intent of lowering maintenance corticosteroid exposure. Outcomes include steroid dose reduction, symptom control measured by MG-ADL and other clinical scales, and the impact on steroid-related comorbidities and safety in an older population. The protocol requires stable concomitant treatments for at least three months and regular clinic visits at the study site for monitoring.

Why it matters

Potential benefit: If successful, patients may be able to lower or stop long-term corticosteroids, reducing steroid-related risks like infections, diabetes, hypertension, osteoporosis and improving quality of life.

How similar studies have gone: Efgartigimod has demonstrated symptomatic benefit in prior trials for AChR-positive gMG (e.g., ADAPT) and shown steroid-sparing potential, but dedicated corticosteroid-sparing data specifically in elderly patients remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • CHU de Nice
    Nice, Alpes-Maritimes, France     Recruiting
  • Hôpital Henri Mondor
    Créteil, France     Recruiting
  • CHU de Grenoble
    Grenoble, France     Recruiting
  • Hôpital Roger Salengro
    Lille, France     Recruiting
  • CHU de la Timone
    Marseille, France     Recruiting
  • CHRU de Nancy
    Nancy, France     Recruiting
Show 3 more locations
  • CHU Charles Nicolle
    Rouen, France     Recruiting
  • CHU de Toulouse
    Toulouse, France     Recruiting
  • Hôpital Raymond Pointcarré
    Garches, France     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.