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

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

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

Conditions3

Interventions2

Locations5 sites

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