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

Launched by AMGEN · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called inebilizumab for people with Neuromyelitis Optica Spectrum Disorder (NMOSD), a condition that affects the nervous system. The trial aims to understand how long-term use of inebilizumab affects certain immune system markers in the blood, specifically immunoglobulins (which are important for fighting infections) and B-cells (a type of white blood cell). Researchers will also look at how safe the medication is over time and what happens to these immune markers after someone stops taking the drug.

To participate in the trial, individuals must be at least 18 years old and have completed at least two years in a previous related study or be starting treatment with inebilizumab at one of the participating sites. Women who can become pregnant and men who are sexually active with women of childbearing potential will need to follow specific contraception guidelines during the study and for a few months after. Participants will be monitored closely for their health and safety throughout the study, and they can expect regular check-ups and tests to track the effects of the medication. If you're considering joining this trial, it's essential to discuss any health concerns or questions with your doctor.

Gender

ALL

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