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

Neuromyelitis Optica Spectrum Disorder Clinical Trial

— N-MOmentum LT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180278
• Other study ID #: HZNP-UPL-401
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2, 2024
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Intervention

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

Drug:
• 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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong, Prince of Wales Hospital	Hong Kong
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika	Szeged
Korea, Republic of	National Cancer Center - Neurology Clinic	Goyang-si	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul
Thailand	Srinagarind Hospital, Department of Medicine- Faculty of Medicine Khon Kaen University, Academic Clinical Research Office (ACRO)	Mueang	Khon Kaen
Thailand	Khon Kaen University, Srinagarind Hospital	Mueang Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Hong Kong,  Hungary,  Korea, Republic of,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time	This will be assessed via serum samples, drawn at the site and processed at a central laboratory, and analyses performed to assess change from baseline over time, as measured by each parameter in mg/dL	Up to 42 months
Primary	Change from baseline in peripheral CD20+ B-cell counts over time	This will be assessed via serum samples, drawn at the site and processed at a central laboratory, and analyses performed to assess change from baseline over time, as measured by each parameter in cells/mL	Up to 42 months
Secondary	Change from baseline in hematology over time	The lab parameters being assessed as part of the hematology analyses include the following: platelet count, red blood cell count, other indices of red blood cells, including MCV (mean corpuscle volume), MCH (mean corpuscle hemoglobin), % reticulocyte count, and morphology (shape); white blood count with differential, including neutrophil count, Lymphocyte count, monocyte count, eosinophils, and basophils; hemoglobin and hematocrit.	Up to 42 months
Secondary	Change from baseline in clinical chemistry over time	The lab parameters being assessed as part of clinical chemistry include blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase.	Up to 42 months
Secondary	Incidence of serious infections		Up to 42 months
Secondary	Incidence of viral reactivation		Up to 42 months
Secondary	Incidence of progressive multifocal leukoencephalopathy (PML)		Up to 42 months
Secondary	Incidence of other opportunistic infections		Up to 42 months
Secondary	Incidence of malignancies		Up to 42 months
Secondary	Incidence of infusion reactions		Up to 42 months
Secondary	Number of protocol-defined NMOSD attacks		Up to 42 months
Secondary	Percentage of protocol-defined NMOSD attacks		Up to 42 months
Secondary	Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers		Up to 42 months