Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Conditions
Sponsors
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of NMO/NMOSD - Confirmation of NMO/NMOSD status: 1. 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 2. 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
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 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
Outcome results
None listed