NCT07072988: OPTIMAGE

Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod

Recruiting now Phase 4 Last updated 24 September 2025

What this trial tests

Phase 4 trial testing Efgartigimod in Myasthenia Gravis, Generalized in 50 participants. Currently enrolling.

Timeline

19 September 2025

Primary endpoint
1 October 2027

1 October 2027

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	19 September 2025
Primary completion	1 October 2027
Estimated completion	1 October 2027
Sites	1 location across France

Drugs / interventions tested

• Efgartigimod — full drug profile →

Conditions studied

• Myasthenia Gravis, Generalized — all drugs for Myasthenia Gravis, Generalized →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

65 and older, any sex, with Myasthenia Gravis, Generalized. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Generalized Myasthenia Gravis (gMG) is a rare chronic autoimmune disorder causing muscle weakness and fatigue, primarily due to autoantibodies that disrupt neuromuscular junction function. The most common antibodies target nicotinic acetylcholine receptors (AChR), with others such as anti-MuSK and anti-LRP4 being less prevalent. The conventional gMG treatments include acetylcholinesterase inhibitors, corticosteroids, immunosuppressant and, in case of myasthenic crisis, plasma exchange (PLEX) and intravenous immunoglobulins (IVIG). Treatment aims to achieve minimal manifestation status (MMS), but many patients face persistent symptoms or side effects. Corticosteroids, while effective, carry significant risks, especially for long-term use, such as, increased infection and cardiovascular risks, chronic conditions like hypertension, diabetes, and osteoporosis and quality of life impacts, including weight gain and mood changes. Elderly patients, who form the majority of the gMG population, are particularly vulnerable due to age-related comorbidities, which limit treatment options and prolong corticosteroid reliance. This contributes to increased mortality, disability, and dependency. Efgartigimod (EFG), a novel therapeutic targeting the neonatal Fc receptor (FcRn), accelerates degradation of pathogenic IgG antibodies, including anti-AChR. Clinical trials demonstrated its efficacy and safety in reducing antibody levels, improving muscle strength, and enhancing quality of life. Both intravenous (IV) and subcutaneous (SC) forms are effective and well tolerated. Approved in the United States and subsequently in Japan and Europe, EFG became available in France in 2023. The present multicenter observational study aims to evaluate the real-life impact of EFG in elderly gMG patients struggling with corticosteroid side effects or comorbidity exacerbations. The objectives of this study include the assessing EFG's ability to enable corticosteroid reduction and monitoring improvements in gMG symptoms, quality of life, comorbidities, and overall health.

This approach highlights a shift towards targeted therapies that balance efficacy with reduced treatment-related burdens for vulnerable gMG populations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.