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Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis | Clinical Trials | Clareo Health

RECRUITING

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

MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis

NCT06967480•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (23)

Clinical Trial Site

Bergamo, Italy

Clinical Trial Site

Bologna, Italy

Clinical Trial Site

Bologna, Italy

Clinical Trial Site

Brescia, Italy

Clinical Trial Site

Florence, Italy

Clinical Trial Site

Imperia, Italy

Clinical Trial Site

Lecco, Italy

Clinical Trial Site

Messina, Italy

Clinical Trial Site

Milan, Italy

Clinical Trial Site

Milan, Italy

Key Dates

Start Date

July 31, 2025

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Generalized Myasthenia GravisAnti-AChR Antibody Positive

Interventions

Ravulizumab

DRUG

Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356 clinicaltrials@alexion.com

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

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Rare DiseasesGeneralized Myasthenia Gravis (gMG)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

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