A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders|
- Time to onset of an adjudicated NMO/NMOSD attack [ Time Frame: From Day 1 of the study until on or before Day 197 of the randomized-controlled period. ]time (days) to onset of an Adjudication Committee (AC) - determined NMO/NMOSD attack
- Attack rate [ Time Frame: 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 ]Annualized attack rate (total number of adjudicated NMO/NMOSD attacks normalized by person-years) during the duration of the Open-label Period
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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 CMAX [ Time Frame: 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.
- Incidence of anti-drug antibodies (ADAs) directed against MEDI-551 [ Time Frame: 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 ]
|Actual Study Start Date:||January 6, 2015|
|Estimated Study Completion Date:||July 26, 2021|
|Estimated Primary Completion Date:||July 29, 2019 (Final data collection date for primary outcome measure)|
|Experimental: MEDI551||Biological: MEDI-551|
|Placebo Comparator: Placebo||
MEDI-551 is a genetically engineered humanized monoclonal antibody that binds to the B cell specific surface antigen CD19 resulting in the depletion of B cells. CD19 positive (CD19+) B-lineage plasmablasts are responsible for the production of autoantibodies against the AQP4 channel protein.
The main objective of this study is to determine whether MEDI-551 compare to placebo decreases the risk of an attack in subjects with NMO/NMOSD.
This is a multicenter, multinational, randomized, double-masked, placebo controlled study with an open-label extension period to evaluate the efficacy and safety of intravenous (IV) MEDI-551 in adult subjects with NMO/NMOSD.
After a screening period, eligible subjects will enter a randomized-controlled period (RCP) of maximum 197 days where they will be randomized in a 3:1 ratio to receive either IV MEDI-551 or placebo. NMO/NMOSD attacks will be evaluated by the investigator and confirmed against the attack criteria by an independent Adjudication Committee (AC). Subjects for whom the attack was confirmed by the AC will be given the option to enroll into an open label period (OLP) with MEDI-551 treatment. Subjects who complete the RCP without experiencing an attack will be given the option to enroll into an OLP with MEDI-551 treatment. The OLP will continue for a minimum of 1 year and a maximum of 3 years after the last subject enter the OLP.
All subjects who discontinue from the RCP or the OLP will continue in a Safety Follow-up for a total of 12 months from last dose to evaluate the long-term safety of the investigational product.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02200770
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
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