Status:
COMPLETED
N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
MedImmune LLC
Conditions:
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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/N...
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. Inebil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2020
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT02200770
Start Date
April 1 2015
End Date
November 6 2020
Last Update
December 3 2021
Active Locations (98)
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1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Sacramento, California, United States, 95817
3
Research Site
San Francisco, California, United States, 94158
4
Research Site
Aurora, Colorado, United States, 80010