A single arm study to investigate OCS tapering in adult participants with generalized Myasthenia Gravis treated with ravulizumab

Prior treatment

• Concurrent participation in an interventional clinical trial.
• Use of concomitant OCS for comorbid conditions other than gMG.

Other illness

• History of chronic hypoadrenalism (ie, Addison’s disease).

Other

• 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

• Aged ≥ 18 years at the time of enrollment.
• Clinical diagnosis of gMG.
• Receiving ravulizumab treatment prior to enrollment, in accordance with the locally approved label
• Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment. - Alternative dosing of OCS (such as every other day) is allowed at enrollment, provided the average daily dose per week is equivalent to ≥ 7.5 mg of prednisone/prednisolone and the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1. - The use of other OCS (e.g., methylprednisolone) is allowed prior to enrolment provided the participant is willing to switch to a daily intake of prednisone/prednisolone at Baseline/Visit 1
• Male or female assigned at birth
• Agrees to follow protocol-specified contraception guidance as outlined in Section 10.5
• 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, see Section 8.3.3 Pregnancy Testing. • Additional requirements for pregnancy testing at Visit 3 are located in Section 8.3.3 Pregnancy Testing
• Willing to provide informed consent as described in Section 10.1.3.