Long-term safety assessment of inebilizumab for treating neuromyelitis optica spectrum disorder

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

This study is trying to see how safe inebilizumab is for people with neuromyelitis optica spectrum disorder over a long time and how it affects their immune system.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amgen (Industry-sponsored)
• Drugs / interventions: inebilizumab, rituximab
• Locations: 11 sites (Detroit, Michigan and 10 other locations)
• Trial ID: NCT06180278 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term effects of inebilizumab on patients with neuromyelitis optica spectrum disorder (NMOSD), focusing on the safety profile and changes in immunoglobulin levels and B-cell counts. It aims to enroll 30 participants, including those who have previously participated in a related study or are newly starting treatment. The study will monitor participants' immunoglobulin levels and B-cell counts during and after treatment to understand the drug's long-term impact. Blood tests will be conducted to gather necessary safety data throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have either completed at least 2 years in a previous related study or are newly initiating inebilizumab treatment.

Not a fit: Patients who are not eligible due to not meeting the inclusion criteria or those who have contraindications to inebilizumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and immunological effects of inebilizumab, potentially improving treatment strategies for NMOSD patients.

How similar studies have performed: Previous studies have shown promising results with inebilizumab for NMOSD, indicating that this approach is built on a foundation of prior success.

Eligibility criteria

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

Where this trial is running

Detroit, Michigan and 10 other locations

• Wayne State University School of Medicine — Detroit, Michigan, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• Vseobecna fakultni nemocnice v Praze - Neurologicka klinika — Praha 2, Czechia (Recruiting)
• Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology — Hong Kong, Hong Kong (Recruiting)
• Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály — Szeged, Csongrád, Hungary (Recruiting)
• National Cancer Center - Neurology Clinic — Goyang-si, Gyeonggido [Kyonggi-do], Korea, Republic of (Recruiting)
• Seoul National University Hospital — Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of (Recruiting)
• Samsung Medical Center - Pediatric Neurology — Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of (Recruiting)
• Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii — Warszawa, Mazowieckie, Poland (Recruiting)
• M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM — Katowice, Slaskie, Poland (Recruiting)
• Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart — Khon Kaen, Thailand (Recruiting)

Study contacts

• Study coordinator: Amgen Call Center

Conditions Neuromyelitis Optica Spectrum Disorder; Immunoglobulins; B-cell count; inebilizumab; Uplizna