Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Last updated: April 16, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

4

Condition

Multiple Sclerosis

Treatment

Inebilizumab

Blood tests

Clinical Study ID

NCT06180278
HZNP-UPL-401
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety measures, and to further monitor repletion of immunoglobins and B-cell counts in participants with NMOSD who discontinue treatment. The objectives include:

  1. To establish the nadir in circulating immunoglobulins (Ig) during chronic treatment with inebilizumab and ascertain the time needed to ensure restoration of pre-treatment baseline serum levels of IgG and IgM after discontinuation of treatment

  2. To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels)

  3. To assess long-term safety of inebilizumab

  4. To assess other long-term effects of inebilizumab

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or above, and able to provide written informed consent and any locallyrequired authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America (USA), European Union [EU] Data PrivacyDirective in the EU) obtained from the subject/legal representative prior toperforming any protocol-related procedures, including screening evaluations.

  2. Have completed at least 2 years in the open-label period of the N-MOmentum study orare newly initiating inebilizumab treatment at a participating site.

  3. Females of childbearing potential who are sexually active with a nonsterilized malepartner must use a highly effective method of contraception as outlined in theprotocol (subjects in the Czech Republic only must use 1 additional method ofcontraception) from screening, and must agree to continue using such precautions for 6 months after treatment with inebilizumab; cessation of contraception after thispoint should be discussed with a responsible physician.

  4. Nonsterilized males who are sexually active with a female partner of childbearingpotential must use a male condom plus spermicide (subjects in the Czech Republiconly must use 1 additional method of contraception) from Day 1 for 3 months afterreceipt of last treatment with inebilizumab.

  5. Sterilized males, without the appropriate post-vasectomy documentation on theabsence of sperm in the ejaculate, who are sexually active with a female partner ofchildbearing potential must use a condom and spermicide from Day 1 for 3 monthsafter receipt of the last treatment with inebilizumab.

Exclusion

Exclusion Criteria:

  1. Have any condition that would place the participant at unacceptable risk ofcomplications, interfere with evaluation of inebilizumab or confound theinterpretation of participant safety or study results.

  2. Received rituximab or any other B-cell depleting agent after exit from N-MOmentumstudy, or within the last 12 months prior to screening for non N-MOmentumparticipants.

  3. Known history of allergy or reaction to any component of inebilizumab formulation orhistory of anaphylaxis following any biologic therapy

  4. Have a severe clinically significant infection, including active chronic infectionsuch as hepatitis B

  5. Have active or untreated latent tuberculosis

  6. Have a history of progressive multifocal leukoencephalopathy (PML)

  7. Is severely immunocompromised state

  8. Have active malignancies

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Inebilizumab
Phase: 4
Study Start date:
April 02, 2024
Estimated Completion Date:
June 02, 2028

Study Description

This study aims to enroll 30 participants who either participated in the open-label period (OLP) of the N-MOmentum study (CD-IA-MEDI-551-1155; NCT02200770), a global registrational study that determined the safety and efficacy of inebilizumab for treatment of NMOSD, or who are newly initiating inebilizumab treatment at the discretion of their physician at participating sites.

Acquired from Horizon in 2024.

Connect with a study center

  • Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology

    Hong Kong, 0000
    China

    Active - Recruiting

  • Prince of Wales Hospital - Department of Medicine & Therapeutics

    Hong Kong, 0000
    China

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 128 21
    Czechia

    Active - Recruiting

  • Prince of Wales Hospital - Department of Medicine & Therapeutics

    Hong Kong, 0000
    Hong Kong

    Site Not Available

  • The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital - Department of Medicine & Therapeutics

    Hong Kong SAR, 0000
    Hong Kong

    Site Not Available

  • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád 6725
    Hungary

    Active - Recruiting

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika

    Szeged, 6725
    Hungary

    Active - Recruiting

  • National Cancer Center - Neurology Clinic

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

    Active - Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggido [Kyonggi-do] 10408
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 06351
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center - Pediatric Neurology

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 03080
    Korea, Republic of

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne WUM

    Warszawa, Mazowieckie 02-097
    Poland

    Active - Recruiting

  • M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

    Katowice, Slaskie 40-751
    Poland

    Active - Recruiting

  • Srinagarind Hospital, Department of Medicine- Faculty of Medicine Khon Kaen University, Academic Clinical Research Office (ACRO)

    Mueang, Khon Kaen 40002
    Thailand

    Site Not Available

  • Khon Kaen University, Srinagarind Hospital

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Khon Kaen University, Srinagarind Hospital

    Mueang Khon Kaen, 40002
    Thailand

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030-4202
    United States

    Active - Recruiting

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