Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm Phase 4 study of adults with acetylcholine receptor–positive generalized myasthenia gravis who are already receiving ravulizumab. Eligible participants must have been taking at least 7.5 mg/day prednisone (or equivalent) for at least four continuous weeks prior to enrollment and will follow a predefined oral corticosteroid taper while continuing ravulizumab. The study will track steroid dose reduction, disease control, and adverse events during and after the taper. Data collected at U.S. research sites will inform whether this tapering approach can be implemented safely in routine care.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Raleigh, North Carolina, United States Recruiting
• Research Site
  Chicago, Illinois, United States Not yet recruiting
• Research Site
  Schaumburg, Illinois, United States Not yet recruiting
• Research Site
  Neptune City, New Jersey, United States Not yet recruiting
• Research Site
  Knoxville, Tennessee, United States Not yet recruiting
• Research Site
  Bochum, Germany Not yet recruiting

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.