Identifying markers for effective treatment of Myasthenia Gravis with complement inhibitors
Official title: Identification of Clinical, Biological, Cellular and Genetic Markers of Favorable Response Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06455709 · Data updated 2026-11-12
This study is trying to find out which markers can help doctors know if complement inhibitor therapy will work well for people with generalized Myasthenia Gravis who have anti-AChR antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | Eculizumab |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 5, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT06455709 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with generalized anti-AChR positive Myasthenia Gravis who require complement inhibitor therapy.
✕Probably not a fit
Patients under 18 years old, those with poor compliance to therapy, or those with other autoimmune diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with generalized Myasthenia Gravis who are positive for anti-AChR antibodies. It aims to identify specific markers that indicate a favorable response to complement inhibitor therapy, which has been recently approved for treatment. The study will involve monitoring patients who meet the eligibility criteria and require therapy with these drugs, assessing their clinical outcomes and biological responses. The findings could help tailor treatments for better patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with Myasthenia Gravis.
How similar studies have gone: Other studies have shown promise in using complement inhibitors for Myasthenia Gravis, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Diagnosis of generalized anti-AChR positive Myasthenia Gravis; * Need for therapy with complement inhibitor drugs according to the therapeutic indications approved by AIFA (16); * Ability to perform follow-up at the reference center; * Signed informed consent to the study. Exclusion Criteria: * Age \<18 years; * Poor compliance with drug therapy; * Concomitant autoimmune diseases; * Insufficient availability of clinical information; * Ongoing neoplasia or infection at the time of biological sample collection; * Refusal to sign the informed consent to the study
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Raffaele Iorio — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Raffaele Iorio, MD, PhD
- Email: raffaele.iorio@policlinicogemelli.it
- Phone: +390630154807
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MG patient registry to track long-term experiences and treatment patterns
This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.
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Panorama: Neuromuscular Organoids to understand refractory AChR+ myasthenia gravis
This study tests neuromuscular organoids built from stem cells to see if they reveal why some people with AChR-positive myasthenia gravis don’t respond to standard treatments.
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Claseprubart in adults with generalized myasthenia gravis
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Aritinercept for generalized myasthenia gravis
This study tests whether aritinercept is safe and helpful for adults with generalized myasthenia gravis compared with placebo.
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MyoSense 360 in generalized myasthenia gravis: testing digital monitoring to track change
This study tests whether a digital monitoring system can detect meaningful changes in generalized myasthenia gravis over a year in adult patients using a smartphone app and wearable device.
-
Corticosteroid-sparing efgartigimod for elderly AChR-positive generalized myasthenia gravis
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.