Biogen Commences Dosing In Late-Stage Systemic Lupus Erythematosus Study With BIIB059

Biogen Inc BIIB has dosed the first patient in the TOPAZ-1 Phase 3 study evaluating BIIB059 in participants with active systemic lupus erythematosus (SLE).
The 540-subject trial will assess the efficacy and safety of BIIB059 compared with placebo.
Participants will be randomized to receive subcutaneous treatment with BIIB059 at one of two doses or placebo every four weeks with an additional dose at Week 2, in addition to their existing lupus therapy.
The primary objective of TOPAZ-1 is to demonstrate a reduction in disease activity as measured with the primary endpoint, the proportion of participants who achieve an SLE Responder Index-4 (SRI-4) response at Week 52.
BIIB059 is a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2.
Price Action: BIIB shares are up 0.56% at $393.52 during the premarket session on the last check Thursday.