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Biogen Reports First Patient Dosing in P-III TOPAZ-1 Study of BIIB059 to Treat Systemic Lupus Erythematosus

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Biogen Reports First Patient Dosing in P-III TOPAZ-1 Study of BIIB059 to Treat Systemic Lupus Erythematosus

Shots:

  • The first patient has been dosed in the P-III TOPAZ-1 study evaluating efficacy & safety of BIIB059 vs PBO in 540 adults with active SLE for 52 wks. The trial is expected to conduct at ~135 sites globally
  • The 1EPs of study are to demonstrate a reduction in disease activity- proportion of patients achieve an SRI-4 response @ 52 wks. & 2EPs will evaluate the effect of BIIB059 on additional efficacy parameters include patients achieve SRI-4 response @ 24 wks. & evaluates the safety
  • The results from the P-II LILAC study support the initiation of the P-III TOPAZ-1 study. The LILAC study met its 1EPs & demonstrates a significant reduction of disease activity & the majority of AEs were mild or mod.

Ref: Biogen | Image: Biogen

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