Health Condition 1: null- Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders Health Condition 2: G360- Neuromyelitis optica [Devic]
Conditions
Interventions
Intervention1: Medi-155: During both the Randomized Controlled Period and the Open Label Period, MEDI-551 (300 mg) will be administered as an IV infusion using the following guidelines:
- MEDI-551 mus
Sponsors
MedImmune LLC a wholly owned subsidiary of AstraZeneca PLC
PPD Pharmaceuticals India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women 18 years or older with diagnosis of NMO/NMOSD 2. 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 3. Able and willing to give written informed consent and comply with the requirements of the study protocol. 4. EDSS less than or equal to 7.5 (8 in special circumstances) 5. 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: 1. Lactating and pregnant females 2. Treatment with any investigational agent within 4 weeks of screening 3. Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy. 4. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization. 5. History of alcohol, drug, or chemical abuse, or a recent history of such abuse less than 1 year prior to randomization 6. Receipt of the following at any time prior to randomization: - Alemtuzumab - Total lymphoid irradiation - Bone marrow transplant - T-cell vaccination therapy 7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal. 8. Receipt of IVIG within 1 month prior to randomization. 9. Receipt of any of the following within 3 months prior to randomization: - Natalizumab (Tysabri®)b. - Cyclosporin - Methotrexate - Mitoxantrone - Cyclophosphamide - Tocilizumab - Eculizumab 10. History of Hepatitis B and/or Hepatitis C (Hep B/C at screening) 11. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection 12. History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy greater than 3 months prior to randomization 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of an adjudicated NMO/NMOSD attackTimepoint: From Day 1 of the study until on or before Day 197 of the randomized-controlled period | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Anti-Drug Antibodies (ADAs) Directed Against MEDI-551Timepoint: From the start of treatment with investigational product until the end of the Safety Follow-up Period, for a total of 12 months following the last dose of investigational product. Incidence of anti-drug antibodies (ADAs) directed against MEDI-551 (both predose and postdose for each subject).;Number of NMO/NMOSD-Related In-Patient HospitalizationsTimepoint: From the start of treatment with invesigational product up to Day 197 of Randomised Control Period.;Number of Participants with Adverse Events as a Measure of Safety and TolerabilityTimepoint: From the start of treatment with investigational product until the end of the Safety Follow-up Period, for a total of 12 months following the last dose of investigational product. Treatment-emergent adverse events, treatment-emergent serious adverse events (TESAEs), including laboratory measurements as well as their changes or shift from baseline over time.;TMAX and CMAXTimepoint: From Day 1 of the study until on or before Day 197 of the randomized-controlled period. Mean MEDI-551 concentration versus time data will be plotted by AQP4-IgG seropositive and seronegative subjects.;Worsening in EDSSTimepoint: From the start of treatment with invesigational product up to Day 197 of Randomised Control Period. Worsening from baseline in EDSS at last visit during the RCP.;Attack RateTimepoint: Annualized attack rate normalized by person/years during the open-label period, for a minimum of 1 year after the last subject enters and a maximum of 3 years after the last subject enters;Change in Low-Contrast Visual Acuity Binocular ScoreTimepoint: From the start of treatment with invesigational product up to Day 197 of Randomised Control Period. Change from baseline in low-contrast visual acuity binocular score measured by low-contrast Landolt C Broken Rings Chart.;Cumulative Total Active MRI LesionsTimepoint: From the start of treatment with invesigational p | — |
Countries
Australia, Bulgaria, Canada, China, Colombia, Czech Republic, Estonia, Germany, Greece, Hong Kong, Hungary, India, Israel, Japan, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Kaushik Mandal
M/s AstraZeneca Pharma India Ltd
Outcome results
None listed