Nizhniy Novgorod, Russian Federation, 603155 Vancouver, British Columbia, Canada, V6T 2B5 Raleigh, North Carolina, United States, 27607 Saint Louis, Missouri, United States, 63131-2374 Rochester, Minnesota, United States, 55905 Kansas City, Kansas, United States, 66160īaltimore, Maryland, United States, 21287 New Haven, Connecticut, United States, 06511 San Francisco, California, United States, 94158 Sacramento, California, United States, 95817 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 daysīirmingham, Alabama, United States, 35294.Able and willing to give written informed consent and comply with the requirements of the study protocol.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.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.Men and women 18 years or older with diagnosis of NMO/NMOSD.All participants 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. The OLP will continue for a minimum of 1 year and a maximum of 3 years after the last participant enter the OLP. Participants who complete the RCP without experiencing an attack will be given the option to enroll into an OLP with inebilizumab treatment. Participants for whom the attack was confirmed by the AC will be given the option to enroll into an open label period (OLP) with inebilizumab treatment. NMO/NMOSD attacks will be evaluated by the investigator and confirmed against the attack criteria by an independent Adjudication Committee (AC). After a screening period, eligible participants 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 inebilizumab or placebo. 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) inebilizumab in adult participants with NMO/NMOSD. The main objective of this study is to determine whether inebilizumab compare to placebo decreases the risk of an attack in participants with NMO/NMOSD. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells, which are generally CD19 positive and CD20 negative. 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. Why Should I Register and Submit Results?.
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