#Option 5 destination phase plus#

DESTINATION will also evaluate the clinical effect of tezepelumab after treatment cessation. DiscussionДESTINATION will evaluate the long-term safety, tolerability and efficacy of tezepelumab versus placebo with continued dosing for up to 2В years. Patients recruited from NAVIGATOR who complete 100В weeks of tezepelumab treatment will be eligible for either 12В weeks of follow-up or a 36-week extended follow-up during which the clinical benefit of tezepelumab after treatment cessation will be investigated. Patients recruited from SOURCE will be followed up post-treatment for 12В weeks. The secondary objective is to assess the long-term effect of tezepelumab on asthma exacerbations.

The primary objective is to evaluate the long-term safety and tolerability of tezepelumab over 104В weeks (inclusive of the treatment period of either predecessor study). Patients will receive their prescribed controller medications throughout DESTINATION and study physicians will have the opportunity to down- or up-titrate dosage of these medications, if appropriate. Patients who were randomized to receive tezepelumab 210В mg every 4В weeks (Q4W) in either predecessor study will continue to receive this regimen for 1В year those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210В mg Q4W or placebo for 1В year. The study population will comprise patients who complete the 52- and 48-week NAVIGATOR and SOURCE studies, respectively.

#Option 5 destination phase plus#

MethodsДESTINATION is a randomized, double-blind, placebo-controlled LTE study in adults (18вЂ“80В years old) and adolescents (12вЂ“17В years old) with severe, uncontrolled asthma who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids. DESTINATION (NCT03706079) is a long-term extension (LTE) of these studies. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, phase 3, randomized, double-blind, placebo-controlled studies (NAVIGATOR and SOURCE ).

Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.