Recruiting

OCS with Ravulizumab

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT07221838

Conditions

Generalized Myasthenia Gravis

gMG

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Corticosteroid Tapering Schedule

Ravulizumab

Prednisone/Prednisolone

Study Details

Brief summary:

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.

Conditions

Generalized Myasthenia Gravis

gMG

Study ID

NCT07221838

Start date

Mar 4, 2026

Status verified date

Mar, 2026

Completion date

Aug 27, 2027

Anticipated

Primary completion date

Aug 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Corticosteroid Tapering Schedule

During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete

Interventions

Oral Corticosteroid Tapering Schedule

During the tapering period, participant will follow an Oral Corticosteroid tapering schedule as applicable to the participant. The oral corticosteroid (prednisone/prednisolone) is provided as per standard medical care.

Ravulizumab

Patients being treated with intravenous ravulizumab as part of their standard medical care.

Prednisone/Prednisolone

Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.

Primary outcome measure

  • Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG [ Time Frame: Up to approximately 32 weeks ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356clinicaltrials@alexion.com

Locations

Research Site

Recruiting

Raleigh, North Carolina, United States, 27607

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Apr 9, 2026

Last verified

Mar, 2026

Keywords

  • Generalized myasthenia gravis
  • gMG
  • Glucocorticoid toxicity
  • Complement C5 inhibitor
  • Prednisone reduction
  • Cortisol monitoring
  • ravulizumab
  • corticosteroids
  • adrenal insufficiency
  • steroid sparing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-04-09.