PROMPT
Identification of Proteomic Changes in Patients With Generalized Myasthenia Gravis Treated With Ravulizumab: Insights Into Neuromuscular Junction Regeneration
Sponsor study identifier
observational
24
1 country
1
Study Start
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2025
Actual (reported)January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 13, 2026
Actual (reported)January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To identify significant changes in plasma protein profiles in patients with generalized myasthenia gravis (gMG) treated with Ravulizumab.
To identify changes in plasma proteins after 10 and 26 weeks of treatment with Ravulizumab compared with baseline, using proteomic technology.
26 weeks
To identify plasma proteins associated with a clinically meaningful improvement in patients with gMG.
26 weeks
To identify potential biomarkers of neuromuscular junction regeneration in patients with gMG.
24 months
Patients with generalized Myasthenia Gravis positive for anti-AChR antibodies undergoing therapy with Ravulizumab
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
Raffaele Iorio, Prof
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
December 19, 2025
First Posted
January 13, 2026
Study Start
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 13, 2026
Record last verified: 2025-12
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