Tests a steroid tapering schedule in adults with generalized myasthenia gravis on ravulizumab
Tests a schedule for lowering oral steroids in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Key facts
- Where
- Naples and Rome, ItalySee the 2 sites
- Phase
- Phase 4
Where in Italy
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alexion Pharmaceuticals, Inc.
- Trial code
- NCT07221838EU 2025-522555-26-00
- Record updated
- 9 April 2026
- Original description
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.Read full original descriptionShow less
OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
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.
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; Use of concomitant OCS for comorbid conditions other than gMG; History of chronic hypoadrenalism (ie, Addison's disease); 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.