Who is eligible for clinical trial NCT06180278?

Participants must meet the protocol's inclusion criteria for Neuromyelitis Optica Spectrum Disorder. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06180278 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-19

Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) (NCT06180278)

A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)

🔵 Active, Not Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Amgen

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).

Location: Wayne State University School of Medicine — Detroit, Michigan

Age range: 18 Years

🧪 Interventions in This Study

Inebilizumab (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.
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.
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.
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.
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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.
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.
Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis following any biologic therapy
Have a severe clinically significant infection, including active chronic infection such as hepatitis B
Have active or untreated latent tuberculosis
Have a history of progressive multifocal leukoencephalopathy (PML)
Is severely immunocompromised state
Have active malignancies

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

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,
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika — Prague,
Szegedi TudomÃ¡nyegyetem, Ã OK, Szent-GyÃ¶rgyi Albert Klinikai KÃ¶zpont - NeurolÃ³giai OsztÃ¡ly — 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,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Neuromyelitis Optica Spectrum Disorder

Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy — Aurora, Colorado
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies — Washington D.C., District of Columbia
A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) — Denver, Colorado
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD — Washington D.C., District of Columbia
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder — La Jolla, California

Explore by condition: All Neuromyelitis Optica Spectrum Disorder clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗