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

Last updated: April 6, 2026
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Wolman Disease

Polymyositis (Inflammatory Muscle Disease)

Hyponatremia

Treatment

Prednisone/Prednisolone

Ravulizumab

Oral Corticosteroid Tapering Schedule

Clinical Study ID

NCT07221838
D9281R00005
ALX-MG-502
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofprednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment

  • A participant of childbearing potential must have a negative highly sensitivepregnancy test (serum or urine, as required by local regulations) taken at Screeningbefore OCS tapering begins.

  • Willing to sign informed consent

Exclusion

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

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Prednisone/Prednisolone
Phase: 4
Study Start date:
March 04, 2026
Estimated Completion Date:
August 27, 2027

Connect with a study center

  • Research Site

    Bochum, 44789
    Germany

    Site Not Available

  • Research Site

    Bochum 2947416, 44789
    Germany

    Site Not Available

  • Research Site

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Research Site

    Milan, 20122
    Italy

    Site Not Available

  • Research Site

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Research Site

    Naples, 80131
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Research Site

    Rome, 00189
    Italy

    Site Not Available

  • Research Site

    Rome 3169070, 00189
    Italy

    Site Not Available

  • Research Site

    Ibaraki, 305-8576
    Japan

    Site Not Available

  • Research Site

    Ibaraki 1862033, 305-8576
    Japan

    Site Not Available

  • Research Site

    Kitakyushu-shi, 807-8555
    Japan

    Site Not Available

  • Research Site

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Research Site

    Kumamoto 1858421, 860-8556
    Japan

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Research Site

    Schaumburg, Illinois 60173
    United States

    Site Not Available

  • Research Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Research Site

    Schaumburg 4910713, Illinois 4896861 60173
    United States

    Site Not Available

  • Research Site

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Research Site

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • Research Site

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Research Site

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Research Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Research Site

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Site Not Available

  • Research Site

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

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