A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab (OCTAGON)

Alexion Pharmaceuticals

Status and phase

Begins enrollment this month

Phase 4

Conditions

gMG

Generalized Myasthenia Gravis

Treatments

Procedure: Oral Corticosteroid Tapering Schedule

Drug: Prednisone/Prednisolone

Drug: Ravulizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07221838

D9281R00005

ALX-MG-502 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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