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NCT07221838PHASE4Recruiting

A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab

Alexion Pharmaceuticals, Inc.

Start Date

3/4/2026

Completion Date

8/27/2027

Summary

This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Aged greater than 18 years and male or female * Clinical diagnosis of gMG * Receiving ravulizumab treatment prior to enrollment * Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment * A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins. * Willing to sign informed consent Exclusion Criteria: * Concurrent participation in an interventional clinical trial. * History of chronic hypoadrenalism (ie, Addison's disease). * Use of concomitant OCS for comorbid conditions other than gMG * Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment * Pregnant, breastfeeding, or intending to conceive during the course of the study

Interventions

PROCEDURE

Oral Corticosteroid Tapering Schedule

DRUG

Ravulizumab

DRUG

Prednisone/Prednisolone

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Conditions

Generalized Myasthenia GravisgMG

Locations

Research Site

Chicago, Illinois 60637

United States

Research Site

Schaumburg, Illinois 60173

United States

Research Site

Neptune City, New Jersey 07753

United States

Research Site

Raleigh, North Carolina 27607

United States

Research Site

Knoxville, Tennessee 37920

United States

Research Site

Bochum, 44789

Germany

Research Site

Milan, 20122

Italy

Research Site

Naples, 80131

Italy

Research Site

Rome, 00189

Italy

Research Site

Ibaraki, 305-8576

Japan

Research Site

Kitakyushu-shi, 807-8555

Japan

Research Site

Kumamoto, 860-8556

Japan