Studies blood protein changes in myasthenia gravis patients treated with ravulizumab
Looks at blood proteins in adults with generalized myasthenia gravis receiving ravulizumab.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Proteomic Changes in Patients With Myasthenia Gravis and Ravulizumab
- Status
- Not yet recruiting
- People taking part
- 24 people, planned
- Started
- Jan 2026
- Expected to end
- Jan 2028
- Type of study
- Observational
- Record updated
- 13 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with generalized myasthenia gravis who have anti-AChR antibodies and need treatment with ravulizumab.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Generalized myasthenia gravis with anti-AChR antibodies (anti-AChR positive)
- Earlier treatment
- Needs ravulizumab treatment, as approved by the Italian medicines agency (AIFA)
- Biomarker or test result
- Anti-AChR antibodies in the blood (anti-AChR positive)
Main reasons for not taking part
- Under 18 years old
- Other autoimmune diseases at the same time
- Not enough clinical information available
- Cancer or infection at the time the blood sample is taken
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Age ≥18 years
- Diagnosis of generalized anti-AChR positive Myasthenia Gravis
- Need for therapy with Ravulizumab drugs according to the therapeutic indications approved by AIFA
- Signed informed consent to the study
Who cannot take part
- Concomitant autoimmune diseases
- Ongoing neoplasia or infection at the time of biological sample collection
- Age <18 years
- Insufficient availability of clinical information
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, ItalyContact: Raffaele Iorio, MD, PhDNo longer taking part
About the trial
What the trial wants to find out
Myasthenia gravis (MG) is an autoimmune neuromuscular disorder primarily caused by antibodies targeting postsynaptic components of the neuromuscular junction, most commonly the acetylcholine receptor (AChR). In AChR-positive generalized MG, IgG1 and IgG3 antibodies activate the classical complement pathway, leading to membrane attack complex-mediated damage of the postsynaptic membrane and impaired neuromuscular transmission. Complement inhibition has therefore emerged as an effective therapeutic strategy.
Read full original descriptionShow less
Ravulizumab, a long-acting monoclonal antibody targeting complement component C5, has demonstrated clinical efficacy in reducing disease severity in patients with AChR-positive generalized MG. However, clinical responses to complement inhibition remain heterogeneous, and reliable biomarkers to monitor treatment response and neuromuscular junction recovery are currently lacking.
Blood-based proteomics represents a powerful approach for identifying molecular changes associated with disease activity and treatment response. In particular, aptamer-based proteomic platforms such as the SomaScan® assay allow high-throughput, highly sensitive quantification of thousands of circulating proteins from small volumes of plasma or serum.
The primary aim of this study is to identify proteomic changes in patients with generalized MG treated with Ravulizumab, with a specific focus on proteins involved in neuromuscular junction regeneration and repair. By leveraging advanced proteomic technologies in a real-world clinical setting, this study seeks to identify biomarkers that may help monitor treatment response, guide optimization of concomitant immunosuppressive therapies, and improve patient stratification. Ultimately, the identification of molecular pathways associated with neuromuscular junction regeneration may open new therapeutic perspectives for autoimmune neuromuscular disorders.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Identification of Proteomic Changes in Patients With Generalized Myasthenia Gravis Treated With Ravulizumab: Insights Into Neuromuscular Junction Regeneration
- Plain-language title
- Studies blood protein changes in myasthenia gravis patients treated with ravulizumabGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 13 January 2026