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

NCT ID: NCT06180278

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2028-06-26

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 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

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 determined the safety and efficacy of inebilizumab for treatment of NMOSD, or who are newly initiating inebilizumab treatment at the discretion of their physician at participating sites.

Acquired from Horizon in 2024.

Conditions

Neuromyelitis Optica Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with NMOSD exposed to 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 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.

Group Type: OTHER

Blood tests

Intervention Type: OTHER

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

Inebilizumab

Intervention Type: DRUG

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.

Interventions

Blood tests

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

UPLIZNA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Wayne State University School of Medicine

Detroit, Michigan, United States

Baylor College of Medicine

Houston, Texas, United States

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, Hungary

Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii

Warsaw, Masovian Voivodeship, Poland

M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

Katowice, Silesian Voivodeship, Poland

National Cancer Center - Neurology Clinic

Goyang-si, Gyeonggido [Kyonggi-do], South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

Samsung Medical Center - Pediatric Neurology

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart

Khon Kaen, , Thailand

Countries

United States; China; Czechia; Hungary; Poland; South Korea; Thailand

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

HZNP-UPL-401

Identifier Type: -

Identifier Source: org_study_id