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

Recruiting now · Phase 4

Conditions studied: Generalized Myasthenia Gravis, gMG

In brief

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.

Key facts

Study ID

NCT07221838

Run by

Alexion Pharmaceuticals, Inc.

People needed

75

Starts

2026-03-04

Expected to finish

2027-08-27

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Raleigh, North Carolina, United States (enrolling)
• Research Site — Schaumburg, Illinois, United States
• Research Site — Neptune City, New Jersey, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Bochum, Germany
• Research Site — Milan, Italy
• Research Site — Naples, Italy
• Research Site — Rome, Italy
• Research Site — Ibaraki, Japan
• Research Site — Kitakyushu-shi, Japan
• Research Site — Chicago, Illinois, United States
• Research Site — Kumamoto, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.