Status:
NOT_YET_RECRUITING
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Generalized Myasthenia Gravis
gMG
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07221838
Start Date
December 31 2025
End Date
June 30 2027
Last Update
January 6 2026
Active Locations (14)
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1
Research Site
Chicago, Illinois, United States, 60637
2
Research Site
Schaumburg, Illinois, United States, 60173
3
Research Site
Neptune City, New Jersey, United States, 07753
4
Research Site
Raleigh, North Carolina, United States, 27607