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Active, not recruiting Phase 4

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

NCT06180278 · tracked via the Priya Life Science South Korea tracker
Sponsor
Phase
Phase 4
Started
2024-04-02
Last updated
2025-11-21

Condition(s) studied

Neuromyelitis Optica Spectrum Disorder

Investigational drug(s) / intervention(s)

Blood testsInebilizumab →

Blood tests: Participants will have blood tests done at each scheduled visit (approximately every 6 months).

Inebilizumab: Participants with NMOSD who previously enrolled in N-MOmentum study, who participated for at least 2 years in the open label phase (OLP) of the study, and participants newly initiating inebilizumab treatment at the discretion of their treating physician will have hematology, chemistry, B-cell count, serum immunoglobulin (Ig) levels, adverse events, concomitant medications list, NMOSD attacks information, antidrug antibody (ADA) status and titers collected.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 years or above, and able to provide written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] in the United States of America (USA), European Union \[EU\] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations. 2. Have completed at least 2 years in the open-label period of the N-MOmentum study or are newly initiating inebilizumab treatment at a participating site. 3. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception as outlined in the protocol (subjects in the Czech Republic only must use 1 additional method of contraception) from screening, and must agree to continue using such precautions for 6 months after treatment with inebilizumab; cessation of contraception after this point should be discussed with a responsible physician. 4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide (subjects in the Czech Republic only must use 1 additional method of contraception) from Day 1 for 3 months after receipt of last treatment with inebilizumab. 5. Sterilized males, without the appropriate post-vasectomy documentation on the absence of sperm in the ejaculate, who are sexually active with a female partner of childbearing potential must use a condom and spermicide from Day 1 for 3 months after receipt of the last treatment with inebilizumab. Exclusion Criteria: 1. Have any condition that would place the participant at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of participant safety or study results. 2. Received rituximab or any other B-cell depleting agent after exit from N-MOmentum study, or within the last 12 months prior to screening for non N-MOmentum participants. 3. Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis following any biologic therapy 4. Have a severe clinically significant infection, including active chronic infection such 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

Primary outcome measure(s)

  • Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time — Up to 42 months
    This will be assessed via serum samples, drawn at the site and processed at a central laboratory, and analyses performed to assess change from baseline over time, as measured by each parameter in mg/dL
  • Change from baseline in peripheral CD20+ B-cell counts over time — Up to 42 months
    This will be assessed via serum samples, drawn at the site and processed at a central laboratory, and analyses performed to assess change from baseline over time, as measured by each parameter in cells/mL

Trial sites (11)

FacilityCityRegionStatus
Wayne State University School of Medicine Detroit Michigan
Baylor College of Medicine Houston Texas
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology Hong Kong China
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika Prague Czechia
Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály Szeged Csongrád megye
Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii Warsaw Masovian Voivodeship
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM Katowice Silesian Voivodeship
National Cancer Center - Neurology Clinic Goyang-si Gyeonggido [Kyonggi-do]
Seoul National University Hospital Seoul Seoul Teugbyeolsi [Seoul-T'ukp
Samsung Medical Center - Pediatric Neurology Seoul Seoul Teugbyeolsi [Seoul-T'ukp
Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart Khon Kaen Thailand
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06180278 on ClinicalTrials.gov ↗ ← All trials in South Korea