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

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

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

Study Overview

• Status: Recruiting
• Conditions: Neuromyelitis Optica Spectrum Disorder
• Intervention / Treatment: Other: Blood tests; Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong, Prince of Wales Hospital
    • Contact: Mandy Liu; Phone Number: +852-2697-5063; Email: mandyliu@cuhk.edu.hk
    • Principal Investigator: Joseph Choi
  • Hong Kong, Hong Kong, 0000
    • Recruiting
    • Prince of Wales Hospital - Department of Medicine & Therapeutics
• Hungary
  • Szeged, Hungary, 6725
    • Recruiting
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika
    • Principal Investigator: Laszlo Vecsei
    • Contact: Monika Konyane Berenyi; Phone Number: +36 -62545351; Email: office.neur@med.u-szeged.hu
  • Csongrád
    • Szeged, Csongrád, Hungary, 6725
      • Recruiting
      • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Byoung Joon Kim
    • Contact: Mihee Hwang; Phone Number: 82-2-3410-0293; Email: mihee777.hwang@samsung.com
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • Recruiting
      • National Cancer Center - Neurology Clinic
      • Contact: Na Young Park; Phone Number: 82-31-920-1683; Email: sua177@ncc.re.kr
      • Principal Investigator: Ho Jin Kim
  • Gyeonggido [Kyonggi-do]
    • Goyang-si, Gyeonggido [Kyonggi-do], Korea, Republic of, 10408
      • Recruiting
      • National Cancer Center
  • Seoul Teugbyeolsi [Seoul-T'ukp
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 06351
      • Recruiting
      • Samsung Medical Center
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
• Poland
  • Slaskie
    • Katowice, Slaskie, Poland, 40-751
      • Recruiting
      • M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
• Thailand
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Khon Kaen University, Srinagarind Hospital
  • Mueang Khon Kaen, Thailand, 40002
    • Recruiting
    • Khon Kaen University, Srinagarind Hospital
    • Contact: Montathip Saisakda; Phone Number: +66833583162; Email: montatip@kku.ac.th
    • Principal Investigator: Somsak Tiamkao
  • Khon Kaen
    • Mueang, Khon Kaen, Thailand, 40002
      • Recruiting
      • Srinagarind Hospital, Department of Medicine- Faculty of Medicine Khon Kaen University, Academic Clinical Research Office (ACRO)
      • Contact: Jureerat Ratanaphet, RN; Phone Number: +66 08 618 6577; Email: jurepr@kku.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.; Other Names: UPLIZNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Incidence of serious infections		Up to 42 months
Incidence of viral reactivation		Up to 42 months
Incidence of progressive multifocal leukoencephalopathy (PML)		Up to 42 months
Incidence of other opportunistic infections		Up to 42 months
Incidence of malignancies		Up to 42 months
Incidence of infusion reactions		Up to 42 months
Number of protocol-defined NMOSD attacks		Up to 42 months
Percentage of protocol-defined NMOSD attacks		Up to 42 months
Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers		Up to 42 months

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Immunoglobulins; inebilizumab; B-cell count; Uplizna
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Neuromyelitis Optica
• Other Study ID Numbers: HZNP-UPL-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No