N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
About this trial
This is an interventional treatment trial for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders focused on measuring NMO, NMOSD, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorders, autoimmune, demyelination, MEDI-551, monoclonal antibody, Devic's syndrome, B-cell
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo/Inebilizumab
Inebilizumab/Inebilizumab
Aquaporin-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.
AQP4-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.