A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexion Pharmaceuticals, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Oral Corticosteroid Tapering Schedule
- Ravulizumab
- Prednisone/Prednisolone
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov