Status:
ACTIVE_NOT_RECRUITING
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Lead Sponsor:
Amgen
Conditions:
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 monit...
Detailed 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 determin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06180278
Start Date
April 2 2024
End Date
June 26 2028
Last Update
November 21 2025
Active Locations (11)
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1
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201-2153
2
Baylor College of Medicine
Houston, Texas, United States, 77030-4202
3
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology
Hong Kong, China, 0000
4
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika
Prague, Czechia, 128 21