Neuromyelitis Optica Spectrum DisorderPhase 4N-MOmentum LTNCT06180278
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
A Phase 4 study testing Blood tests and Inebilizumab in people with Neuromyelitis Optica Spectrum Disorder, run by Amgen at 11 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder
- What is being tested?
- Blood tests and Inebilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 2 Apr 2024to 26 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
South Korea3 sites
National Cancer Center - Neurology Clinic
Goyang-si, Gyeonggido [Kyonggi-do], 10408
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03080
Samsung Medical Center - Pediatric Neurology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 6351
United States2 sites
Wayne State University School of Medicine
Detroit, Michigan, 48201-2153
Baylor College of Medicine
Houston, Texas, 77030-4202
Poland2 sites
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, Silesian Voivodeship, 40-751
Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii
Warsaw, Masovian Voivodeship, 02-057
China1 site
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology
Hong Kong, 0000
Czechia1 site
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika
Prague, 128 21
Hungary1 site
Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály
Szeged, Csongrád megye, 6725
Thailand1 site
Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart
Khon Kaen, 40002
About this study
Official title: 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:
- 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
- To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels)
- To assess long-term safety of inebilizumab
- To assess other long-term effects of inebilizumab
Read the 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
- Being tested
- Blood tests, Inebilizumab
- Keywords
- Immunoglobulins, B-cell count, inebilizumab, Uplizna
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsOther
Participants will have blood tests done at each scheduled visit (approximately every 6 months).
InebilizumabDrug
Also called UPLIZNA
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with NMOSD exposed to inebilizumab | Other | 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. Receives: Other: Blood tests; Drug: Inebilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 42 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: Up to 42 months
Incidence of serious infections
Measured: Up to 42 months
Incidence of viral reactivation
Measured: Up to 42 months
Incidence of progressive multifocal leukoencephalopathy (PML)
Measured: Up to 42 months
Incidence of other opportunistic infections
Measured: Up to 42 months
Incidence of malignancies
Measured: Up to 42 months
Incidence of infusion reactions
Measured: Up to 42 months
Number of protocol-defined NMOSD attacks
Measured: Up to 42 months
Percentage of protocol-defined NMOSD attacks
Measured: Up to 42 months
Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start2 Apr 2024
- Primary completion26 Jun 2028 (estimated)
- Study completion26 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180278
- Sponsor's protocol ID
- HZNP-UPL-401
- Acronym
- N-MOmentum LT
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)
- ClinicalTrials.gov ID
- NCT06180278
- Acronym / sponsor ID
- N-MOmentum LT / HZNP-UPL-401
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Keywords
- Immunoglobulins, B-cell count, inebilizumab, Uplizna
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 26 Jun 2028 (estimated)
- Study completion
- 26 Jun 2028 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels)
- To assess long-term safety of inebilizumab
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with NMOSD exposed to inebilizumab | Other | Other: Blood tests, Drug: InebilizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testsParticipants will have blood tests done at each scheduled visit (approximately every 6 months). | Other | Participants with NMOSD exposed to inebilizumab |
| InebilizumabAlso: UPLIZNAParticipants 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. | Drug | Participants with NMOSD exposed to inebilizumab |
Primary outcome
Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time
Time frame: Up to 42 months
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
Change from baseline in peripheral CD20+ B-cell counts over time
Time frame: Up to 42 months
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
11 secondary outcomes
Change from baseline in hematology over time
Time frame: Up to 42 months
Change from baseline in clinical chemistry over time
Time frame: Up to 42 months
Incidence of serious infections
Time frame: Up to 42 months
Incidence of viral reactivation
Time frame: Up to 42 months
Incidence of progressive multifocal leukoencephalopathy (PML)
Time frame: Up to 42 months
Incidence of other opportunistic infections
Time frame: Up to 42 months
Incidence of malignancies
Time frame: Up to 42 months
Incidence of infusion reactions
Time frame: Up to 42 months
Number of protocol-defined NMOSD attacks
Time frame: Up to 42 months
Percentage of protocol-defined NMOSD attacks
Time frame: Up to 42 months
Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers
Time frame: Up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood tests and Inebilizumab in people with Neuromyelitis Optica Spectrum Disorder, run by Amgen at 11 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea, United States, Poland, China, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time (time frame: Up to 42 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.