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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT02200770

Run by

MedImmune LLC

People needed

231

Starts

2015-04-01

Expected to finish

2020-11-06

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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

Where it is running

• Research Site — Sacramento, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Maitland, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Mansfield, Ohio, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Melbourne, Australia
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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