Biogen announces first patient enrolled in Phase 3b Nova study
The first patient has been enrolled in a global Phase 3b study evaluating the efficacy and safety of extended interval dosing, or EID, for natalizumab compared to standard interval dosing, or SID, in patients with relapsing multiple sclerosis, or MS, Biogen announced. Currently commercialized under the brand name Tysabri, natalizumab 300 mg dosed every four weeks is the only approved dosing regimen. The new study, NOVA, is a two-year, prospective, randomized, interventional, controlled, open-label, rater-blinded, international Phase 3b study that will assess the efficacy, safety and tolerability of six-week natalizumab dosing intervals in people with relapsing-remitting MS. Patients who switch to EID after one year of treatment with natalizumab SID will be evaluated in relation to patients receiving continued SID treatment. The study will enroll approximately 480 patients worldwide. The primary endpoint is the number of new or newly enlarging T2 hyperintense lesions at week 48.