Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

Last updated: April 23, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Neuropathy

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Treatment

Ravulizumab

Clinical Study ID

NCT05644561
ALXN1210-MG-319
  • All Genders

Study Summary

The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period

  • Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class IIto Class IV at Screening

  • Participants receiving treatment must be on a stable dosing regimen of adequateduration prior to Screening and during the Screening Period.

  • Eculizumab-experienced participants must have been enrolled and treated witheculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have beenon a stable dose for ≥ 2 months (60 days) prior to Screening.

  • All participants must be vaccinated against meningococcal infection

Exclusion

Exclusion Criteria:

Medical Conditions

  • Any untreated thymic malignancy, carcinoma, or thymoma.

  • Participants with a history of treated benign thymoma

  • History of thymectomy, thymomectomy, or any thymic surgery within the 12 monthsprior to Screening

  • History of N meningitidis infection

  • Known to be human immunodeficiency virus (HIV) positive

  • History of unexplained infections

  • Known or suspected history of drug or alcohol abuse or dependence within 1 yearprior to the start of the Screening Period

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Ravulizumab
Phase: 3
Study Start date:
June 24, 2023
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Research Site

    Marseille, 13385
    France

    Active - Recruiting

  • Research Site

    PARIS Cedex 12, 75571
    France

    Site Not Available

  • Clinical Trial Site

    Paris, 75012
    France

    Site Not Available

  • Research Site

    Paris, 75571
    France

    Active - Recruiting

  • Clinical Trial Site

    Milano, 20133
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20133
    Italy

    Active - Recruiting

  • Research Site

    Roma, 00165
    Italy

    Active - Recruiting

  • Research Site

    Torino, 10126
    Italy

    Active - Recruiting

  • Research Site

    Itabashi-ku, 173-0003
    Japan

    Active - Recruiting

  • Clinical Trial Site

    Tokyo, 1738606
    Japan

    Site Not Available

  • Research Site

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Belgrade, 11070
    Serbia

    Active - Recruiting

  • Research Site

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Clinical Trial Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Malaga, 29010
    Spain

    Active - Recruiting

  • Research Site

    Malaga, 29010
    Spain

    Active - Recruiting

  • Research Site

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Research Site

    Los Angeles, California 90078
    United States

    Active - Recruiting

  • Research Site

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Research Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Research Site

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Research Site

    Akron, Ohio 44308
    United States

    Active - Recruiting

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Denton, Texas 76208
    United States

    Active - Recruiting

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