NCT06967480 Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
| NCT ID | NCT06967480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Generalized Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-07-31 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06967480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06967480 currently recruiting?
Yes, NCT06967480 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT06967480 trial being conducted?
This trial is being conducted at Bergamo, Italy, Bologna, Italy, Bologna, Italy, Brescia, Italy and 11 additional locations.
Who is sponsoring the NCT06967480 clinical trial?
NCT06967480 is sponsored by Alexion Pharmaceuticals, Inc.. The trial plans to enroll 40 participants.