Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis

Launched by ALEXION PHARMACEUTICALS, INC. · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Ravulizumab for patients with a type of muscle weakness known as generalized Myasthenia Gravis (gMG) who test positive for anti-AChR antibodies. The main goal is to see if taking Ravulizumab early in the course of the disease can help improve daily living activities for these patients. The trial is currently not yet recruiting participants, but it is looking for adults aged 18 to 75 who have been diagnosed with gMG within the last three years and have moderate to severe symptoms that affect their daily life.

To be eligible for the trial, participants need to have a confirmed diagnosis of gMG, which can be shown through specific tests or improvement in symptoms with certain medications. They also need to have completed their meningitis vaccinations before starting the treatment. However, there are some individuals who cannot participate, such as those who are pregnant, those who have had certain treatments recently, or those who might have trouble understanding the study requirements. Participants in the trial can expect to receive the medication and will be monitored closely by healthcare professionals throughout the study to assess its effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Diagnosis of MG confirmed by:
• • History of a positive serologic test for anti-AChR antibodies, and
• * One of the following:
• • History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation
• • History of positive anticholinesterase test (e.g., edrophonium chloride test); or
• • Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
• • Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
• • MGFA class IIb to IV;
• • Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
• • Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
• Exclusion Criteria:
• • Patient unable to understand and sign the informed consent
• • Hypersensitivity to the active substance or to any of the excipients of the study product
• • Patient for whom the study product is contraindicated according to SmPC
• • Previous treatment with C5 inhibitors
• • Last rituximab infusion performed \< 6 months before T-4 (Enrolment)
• • Last infusion with FcRn blockers performed \< 3 months before T-4 (Enrollment)
• • Pregnant or lactating or planning a pregnancy during the study
• • Patient who plan to relocate during the study
• • Patient who are unsure of following the visit schedule
• • Patient unable to complete questionnaires
• • Previous or current participation to other interventional studies