A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
Alexion Pharmaceuticals, Inc.
75 participants
Mar 4, 2026
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria5
- 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
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Interventions
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule as applicable to the participant. The oral corticosteroid (prednisone/prednisolone) is provided as per standard medical care.
Patients being treated with intravenous ravulizumab as part of their standard medical care.
Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT07221838