Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD

Last updated: April 14, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Multiple Sclerosis

Treatment

Ravulizumab

Clinical Study ID

NCT05346354
ALXN1210-NMO-317
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be anti-AQP4 Ab-positive and have a diagnosis of NMOSD as definedby the 2015 international consensus diagnostic criteria.

  • Complement inhibitor treatment-naïve participants must have had at least 1 attack orrelapse in the last 12 months prior to the Screening Period.

  • Expanded Disability Status Scale (EDSS) score ≤ 7.

  • Eculizumab-experienced participants must be clinically stable per Investigator for 30 days and have been treated with eculizumab in Study ECU-NMO-303 for at least 90days prior to screening with no missed doses within 2 months prior to Day 1.

  • Participants who enter the study receiving supportive IST(s) (eg, corticosteroid,azathioprine [AZA], mycophenolate mofetil [MMF], methotrexate [MTX], tacrolimus [TAC], cyclosporin [CsA], or cyclophosphamide [CYC]) for the prevention of relapse,either in combination or monotherapy, must be on a stable dosing regimen of adequateduration prior to Screening and remain on a stable dosing regimen during theScreening Period.

  • To reduce the risk of meningococcal infection (Neisseria meningitidis), allparticipants must be vaccinated against meningococcal infection.

  • Documented vaccination for Hib and S pneumoniae at least 14 days prior to Day 1according to national/local guidelines for the applicable age group.

Exclusion

Exclusion Criteria:

  • Use of rituximab within 3 months prior to screening.

  • Currently treated with a biologic medications (other than eculizumab) that mayaffect immune system functioning, or has stopped treatment with a biologicmedication that may affect immune system functioning, and 5 half lives of themedication have not elapsed by the time of the Screening Visit.

  • Use of intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 3 weeksprior to Screening.

  • Participation in another investigational drug or investigational device study (otherthan Study ECU-NMO-303) within 5 half lives of that investigational product (ifknown) or 30 days before initiation of the first dose of study drug, whichever islonger.

  • Use of immunomodulatory therapies for multiple sclerosis within 3 months prior toScreening.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Ravulizumab
Phase: 2/3
Study Start date:
June 23, 2022
Estimated Completion Date:
January 02, 2029

Connect with a study center

  • Clinical Trial Site

    Edmonton, Alberta T6G 1C9
    Canada

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 1C9
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montreal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H3T1C5
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • Research Site

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • Research Site

    Marseille, 13005
    France

    Active - Recruiting

  • Clinical Trial Site

    Montpellier, 34295
    France

    Site Not Available

  • Research Site

    Montpellier, 34295
    France

    Active - Recruiting

  • Research Site

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Research Site

    Bochum, 44791
    Germany

    Site Not Available

  • Research Site

    Giessen, 35392
    Germany

    Site Not Available

  • Research Site

    Catania, 95123
    Italy

    Site Not Available

  • Research Site

    Chieti, 66013
    Italy

    Active - Recruiting

  • Research Site

    Gallarate, 21013
    Italy

    Active - Recruiting

  • Research Site

    Roma, 00165
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Rome, 00165
    Italy

    Site Not Available

  • Clinical Trial Site

    Yokohama, Kanagawa 232-0024
    Japan

    Site Not Available

  • Research Site

    Yokohama-shi, 232-0024
    Japan

    Active - Recruiting

  • Clinical Trial Site

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Clinical Trial Site

    Barcelona, 08950
    Spain

    Site Not Available

  • Research Site

    Esplugues de Llobregat, 8950
    Spain

    Active - Recruiting

  • Research Site

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Clinical Trial Site

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Clinical Trial Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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