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Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersPhase 2/3NCT02200770

N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

A Phase 2/3 study testing Inebilizumab in people with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders, run by MedImmune LLC at 98 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inebilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
98 sitesin 25 countries
Study dates
1 Apr 2015to 6 Nov 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Men and women 18 years or older with diagnosis of NMO/NMOSD
  • Confirmation of NMO/NMOSD status:
  • AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
  • AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
  • Able and willing to give written informed consent and comply with the requirements of the study protocol.
  • EDSS <= 7.5 (8 in special circumstances)
  • Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.

Who cannot join

  • Lactating and pregnant females
  • Treatment with any investigational agent within 4 weeks of screening
  • Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
  • Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
  • History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
  • Receipt of the following at any time prior to randomization:
Show all 24Show fewer
  • Alemtuzumab
  • Total lymphoid irradiation
  • Bone marrow transplant
  • T-cell vaccination therapy
  • Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
  • Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization.
  • Receipt of any of the following within 3 months prior to randomization:
  • Natalizumab (Tysabri®).
  • Cyclosporin
  • Methotrexate
  • Mitoxantrone
  • Cyclophosphamide
  • Tocilizumab
  • Eculizumab
  • History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
  • Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
  • History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization
  • Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days

Trial locations and contacts

98 sites in 25 countries.

98 sites in 25 countries

United States19 sites

  • Research Site

    Aurora, Colorado, 80010

  • Research Site

    Baltimore, Maryland, 21287

  • Research Site

    Birmingham, Alabama, 35294

  • Research Site

    Chicago, Illinois, 60637

  • Research Site

    Cincinnati, Ohio, 45219

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Dallas, Texas, 75390

  • Research Site

    Detroit, Michigan, 48201

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Maitland, Florida, 32751

  • Research Site

    Mansfield, Ohio, 44906

  • Research Site

    New Haven, Connecticut, 06511

  • Research Site

    Raleigh, North Carolina, 27607

  • Research Site

    Richmond, Virginia, 23298

  • Research Site

    Rochester, Minnesota, 55905

  • Research Site

    Sacramento, California, 95817

  • Research Site

    San Francisco, California, 94158

  • Research Site

    St Louis, Missouri, 63131-2374

Other trials in United States

Russia11 sites

  • Research Site

    Belgorod, 308007

  • Research Site

    Kazan', 420021

  • Research Site

    Khabarovsk, 680009

  • Research Site

    Krasnoyarsk, 660037

  • Research Site

    Moscow, 123367

  • Research Site

    Moscow, 127018

  • Research Site

    Nizhny Novgorod, 603155

  • Research Site

    Novosibirsk, 63007

  • Research Site

    Omsk, 644033

  • Research Site

    Saint Petersburg, 197110

  • Research Site

    Ufa, 450005

Other trials in Russia

Poland7 sites

  • Research Site

    Katowice, 40-595

  • Research Site

    Krakow, 31-637

  • Research Site

    Lódz, 90-324

  • Research Site

    Lublin, 20-954

  • Research Site

    Olsztyn, 10-560

  • Research Site

    Warsaw, 02-097

  • Research Site

    Warsaw, 02-957

Other trials in Poland

Germany6 sites

  • Research Site

    Berlin, 10117

  • Research Site

    Dresden, 01307

  • Research Site

    Düsseldorf, 40225

  • Research Site

    Leipzig, 04103

  • Research Site

    Münster, 48149

  • Research Site

    Rostock, 18147

Other trials in Germany

Japan6 sites

  • Research Site

    Aomori, 030-8553

  • Research Site

    Bunkyō City, 113-8431

  • Research Site

    Kyoto, 604-8453

  • Research Site

    Ōta-ku, 145-0065

  • Research Site

    Sendai, 980-8574

  • Research Site

    Tsukuba, 305-8577

Other trials in Japan

Turkey (Türkiye)5 sites

  • Research Site

    Istanbul, 34098

  • Research Site

    Istanbul, 34147

  • Research Site

    Istanbul, 34890

  • Research Site

    Izmir, 35170

  • Research Site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Bulgaria4 sites

  • Research Site

    Sofia, 1113

  • Research Site

    Sofia, 1309

  • Research Site

    Sofia, 1431

  • Research Site

    Varna, 9010

Other trials in Bulgaria

Colombia4 sites

  • Research Site

    Barranquilla, 080020

  • Research Site

    Bogotá, 110131

  • Research Site

    Bogotá, 110231

  • Research Site

    Cali, 760032

Other trials in Colombia

Mexico4 sites

  • Research Site

    Mexico City, 03310

  • Research Site

    Mexico City, 14269

  • Research Site

    Monterrey, 64460

  • Research Site

    San Luis Potosí City, 78090

Other trials in Mexico

South Korea4 sites

  • Research Site

    Goyang, 410-769

  • Research Site

    Jongno-gu, 110-744

  • Research Site

    Seoul, 135-710

  • Research Site

    Seoul, 143729

Other trials in South Korea

Czechia3 sites

  • Research Site

    Olomouc, 775 20

  • Research Site

    Prague, 121 11

  • Research Site

    Teplice, 415 29

Other trials in Czechia

Hungary3 sites

  • Research Site

    Esztergom, 2500

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Szeged, 6725

Other trials in Hungary

Israel3 sites

  • Research Site

    Jerusalem, 91120

  • Research Site

    Ramat Gan, 52621

  • Research Site

    Tel Aviv, 6423906

Other trials in Israel

Taiwan3 sites

  • Research Site

    Changhua, 50006

  • Research Site

    Hualien City, 97002

  • Research Site

    Tainan, 70403

Other trials in Taiwan

Thailand3 sites

  • Research Site

    Bangkok, 10700

  • Research Site

    Muang, 40002

  • Research Site

    Muang, 50200

Other trials in Thailand

Estonia2 sites

  • Research Site

    Tallinn, 10617

  • Research Site

    Tartu, 51014

Other trials in Estonia

Peru2 sites

  • Research Site

    Bellavista, CALLAO 2

  • Research Site

    Lima, LIMA 01

Other trials in Peru

South Africa2 sites

  • Research Site

    Cape Town, 7505

  • Research Site

    Cape Town, 7925

Other trials in South Africa

Australia1 site

  • Research Site

    Melbourne, 3065

Other trials in Australia

Canada1 site

  • Research Site

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Hong Kong1 site

  • Research Site

    Hong Kong

Other trials in Hong Kong

Moldova1 site

  • Research Site

    Chisinau, 2028

Other trials in Moldova

New Zealand1 site

  • Research Site

    Auckland, 1023

Other trials in New Zealand

Serbia1 site

  • Research Site

    Belgrade, 11129

Other trials in Serbia

Spain1 site

  • Research Site

    Madrid, 28040

Other trials in Spain

About this study

Official title: A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.

Read the detailed description

Inebilizumab is a genetically engineered humanized monoclonal antibody that binds to the B cell specific surface antigen cluster of differentiation (CD19) resulting in the depletion of B cells. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells, which are generally CD19 positive and CD20 negative.

The main objective of this study is to determine whether inebilizumab compare to placebo decreases the risk of an attack in participants with NMO/NMOSD.

This is a multicenter, multinational, randomized, double-masked, placebo controlled study with an open-label extension period to evaluate the efficacy and safety of intravenous (IV) inebilizumab in adult participants with NMO/NMOSD. After a screening period, eligible participants will enter a randomized-controlled period (RCP) of maximum 197 days where they will be randomized in a 3:1 ratio to receive either IV inebilizumab or placebo. NMO/NMOSD attacks will be evaluated by the investigator and confirmed against the attack criteria by an independent Adjudication Committee (AC). Participants for whom the attack was confirmed by the AC will be given the option to enroll into an open label period (OLP) with inebilizumab treatment. Participants who complete the RCP without experiencing an attack will be given the option to enroll into an OLP with inebilizumab treatment. The OLP will continue for a minimum of 1 year and a maximum of 3 years after the last participant enter the OLP. All participants who discontinue from the RCP or the OLP will continue in a Safety Follow-up for a total of 12 months from last dose to evaluate the long-term safety of the investigational product.

Being tested
Inebilizumab, Placebo
Keywords
NMO, NMOSD, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorders, autoimmune, demyelination, MEDI-551, monoclonal antibody, Devic's syndrome, B-cell
Medical subject headings
Neuromyelitis Optica, Demyelinating Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InebilizumabDrug

    Also called MEDI-551

    Participants will receive IV inebilizumab 300 mg.

  • PlaceboOther

    Participants will receive IV placebo matched to inebilizumab.

Study groups in NCT02200770
Study groupRoleWhat they receive
Placebo/InebilizumabPlacebo comparatorAquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.
Receives: Drug: Inebilizumab; Other: Placebo
Inebilizumab/InebilizumabExperimentalAQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.
Receives: Drug: Inebilizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP

    The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.

    Measured: Day 1 (Baseline) through Day 197

Secondary outcomes (16)

  1. Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP

    EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.

    Measured: Day 1 (Baseline) through Day 197

  2. Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP

    Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.

    Measured: Day 1 (Baseline) through Day 197

  3. Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP

    The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.

    Measured: From Screening (Day -28) to Day 197

  4. Number of NMOSD-related In-patient Hospitalizations During RCP

    Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.

    Measured: Day 1 (Baseline) through Day 197

  5. Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab

    Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.

    Measured: For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)

  6. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.

    Measured: Day 1 (Baseline) through Day 197

  7. Number of Participants With TEAEs and TESAEs During OLP

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.

    Measured: Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)

  8. Number of Participants With TEAEs and TESAEs During SFP (Open-label Population)

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP.

    Measured: Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)

  9. Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population)

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP.

    Measured: Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)

  10. Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP

    Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.

    Measured: Day 1 (Baseline) through Day 197

  11. Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP

    Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.

    Measured: Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)

  12. Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)

    Time to maximum serum concentration of inebilizumab during RCP is reported.

    Measured: Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)

  13. Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)

    Maximum observed serum concentration of inebilizumab during RCP is reported.

    Measured: Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)

  14. Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)

    Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.

    Measured: Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)

  15. Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)

    Number of participants with positive ADA titer to inebilizumab during RCP is reported.

    Measured: Pre and post dose on Day 1; and on Days 29, 85, and 197

  16. Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP)

    Number of participants with positive ADA titer to inebilizumab in OLP is reported.

    Measured: Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2014 (estimated)
  2. Study start1 Apr 2015
  3. Primary completion26 Oct 2018
  4. Study completion6 Nov 2020

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02200770
Sponsor's protocol ID
CD-IA-MEDI-551-1155
Other IDs
2014-000253-36, 2014
Status last verified
Nov 2021
First submitted
16 Jul 2014
Last updated
3 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Publications

  • Bennett JL, Pittock SJ, Paul F, Kim HJ, Irani SR, O'Connor KC, Patterson KR, Smith MA, Gunsior M, Mittereder N, Rees WA, Cimbora D, Cree BAC. B cell and aquaporin-4 antibody relationships with neuromyelitis optica spectrum disorder activity. Ann Clin Transl Neurol. 2024 Oct;11(10):2792-2798. doi: 10.1002/acn3.52171. Epub 2024 Sep 2.

    PubMed 39222408

  • Cree BAC, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, She D, Rees W, Smith M, Cimbora D, Katz E, Bennett JL; N-MOmentum study investigators. Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial. Lancet Neurol. 2024 Jun;23(6):588-602. doi: 10.1016/S1474-4422(24)00077-2.

    PubMed 38760098

  • Aktas O, Hartung HP, Smith MA, Rees WA, Fujihara K, Paul F, Marignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Cutter G, She D, Gunsior M, Cimbora D, Katz E, Cree BA; N-MOmentum study investigators. Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder. J Neurol Neurosurg Psychiatry. 2023 Sep;94(9):757-768. doi: 10.1136/jnnp-2022-330412. Epub 2023 May 23.

    PubMed 37221052

  • Bennett JL, Aktas O, Rees WA, Smith MA, Gunsior M, Yan L, She D, Cimbora D, Pittock SJ, Weinshenker BG, Paul F, Marignier R, Wingerchuk D, Cutter G, Green A, Hartung HP, Kim HJ, Fujihara K, Levy M, Katz E, Cree BAC; N-MOmentum study investigators. Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial. EBioMedicine. 2022 Dec;86:104321. doi: 10.1016/j.ebiom.2022.104321. Epub 2022 Nov 10.

    PubMed 36370634

  • Flanagan EP, Levy M, Katz E, Cimbora D, Drappa J, Mealy MA, She D, Cree BAC. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study. Mult Scler Relat Disord. 2022 Jan;57:103352. doi: 10.1016/j.msard.2021.103352. Epub 2021 Oct 26.

    PubMed 35158461

  • Marignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Green AJ, Aktas O, Hartung HP, Lublin FD, Williams IM, Drappa J, She D, Cimbora D, Rees W, Smith M, Ratchford JN, Katz E, Cree BAC; N-MOmentum Study Investigators. Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 26;8(3):e978. doi: 10.1212/NXI.0000000000000978. Print 2021 May.

    PubMed 33771837

  • Aktas O, Smith MA, Rees WA, Bennett JL, She D, Katz E, Cree BAC; N-MOmentum scientific group and the N-MOmentum study investigators. Serum Glial Fibrillary Acidic Protein: A Neuromyelitis Optica Spectrum Disorder Biomarker. Ann Neurol. 2021 May;89(5):895-910. doi: 10.1002/ana.26067. Epub 2021 Mar 30.

    PubMed 33724534

  • Cree BA, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Williams IM, Drappa J, She D, Cimbora D, Rees W, Ratchford JN, Katz E. Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD. Mult Scler. 2021 Nov;27(13):2052-2061. doi: 10.1177/1352458521988926. Epub 2021 Feb 4.

    PubMed 33538237

  • Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E; N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5.

    PubMed 31495497

  • Cree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14.

    PubMed 26666258

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Inebilizumab in people with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders, run by MedImmune LLC at 98 sites in 25 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 7 inclusion and 24 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: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Russia, Poland, Germany, Japan and 20 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP (time frame: Day 1 (Baseline) through Day 197). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200770, which also lists 10 linked publications.

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 3 Dec 2021.

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