MedImmune: N-MOmentum study (MEDI-551)

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MedImmune: N-MOmentum study (MEDI-551)

Post by HSowalla » Tue Sep 05, 2017 2:03 pm

N-MOmentum study: MEDI-551

The N-MOmentum study is been conducted to test if the drug MEDI-551 will have proven benefits of reducing the risk of NMO or NMOSD attack.

The drug is MEDi-551, this is the active drug. It will be giving 300mg intravenously twice, at Day 1 and at Day 15 and then every 6 months. This is a pure placebo study, which means that no other immunosuppressive treatment will be allowed in the placebo arm. Who will receive MEDi-551 and who will receive the placebo will be chosen at random by a computer. This is called the randomization.

For this study the random selection will give the patients a 75% chance, or 3 in 4, of getting MEDi-551 and 25% chance, or 1 in 4, of getting placebo. This is a double-masked placebo controlled study with an open labeled period. Double-masked means that both the patient and the study stuff, for example your doctor or a nurse given the study drug do not know who is or will be receiving MEDi-551 or placebo. This masked period will last for 6.5 months or 28 weeks. In order to get the information needed the study needs 67 attacks to determine whether MEDi-551 is effective in reducing the risk of a new attack compared to the placebo.

Because this is a pure placebo design, safety is our priority we will monitor our trial participants closely by phone calls every two weeks and through scheduled visits to the doctor. In addition, because it is a placebo design again, your physician is allowed to use rescue medications such as IV steroids or plasmapheresis in case an attack occurs.

In summary, MEDi-551 depletes CD19 B cells, which is the source of the production of the aquaporin IgG AQP4 antibodies that cause NMO and NMOSD. The N-Momentum study is a pure placebo controlled study with a masked treatment period of 6.5 months and a randomization of 3:1, where 75% of patients will be on MEDi-551 and 25% on placebo only. After the randomization controlled period the trial participants will have the option to enter the open-label period where all participants will receive MEDi-551. For any additional information, please visit the link that I have provided in this slide or you can contact AstraZeneca Clinical Study information center at 1-877-240-9479 or email. Thank you very much.

For more information please view: ... medimmune/
Heather Sowalla

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