First patient dosed in phase III TOPAZ-1 study to treat systemic lupus erythematosus - Biogen Inc.

TOPAZ-1 is expected to be conducted at approximately 135 sites worldwide and aims to enroll 540 adults with active SLE.

“A chronic autoimmune condition such as lupus, which overwhelmingly affects women, has a tremendous impact on my patients’ daily lives, including their physical, mental and social wellbeing,” said Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell Health and Professor at Zucker School of Medicine at Hofstra/Northwell. “There remains a significant need for efficacious and generally safe treatment options for lupus patients. Based on the positive results observed in the Phase II LILAC study, we are excited to continue to evaluate the potential of BIIB059 in TOPAZ-1.”

The primary objective of TOPAZ-1 is to demonstrate reduction in disease activity as measured with the primary endpoint, proportion of participants who achieve an SLE Responder Index-4 (SRI-4) response at Week 52. SRI is a composite index using validated indices to measure global and organ-/system-specific disease activity. Key secondary endpoints will evaluate the effect of BIIB 059 on additional efficacy parameters including proportion of patients achieving SRI-4 response at Week 24, oral corticosteroid use, organ-specific disease activity (joint and/or skin) and flare rates. Safety will be evaluated throughout the study duration.

Two investigational lupus assets in Phase III studies: BIIB 059, an anti-BDCA2, and dapirolizumab pegol, an anti-CD40L being developed in collaboration with UCB, which began a Phase III trial in 2020.