Biogen has announced 52-week results from the phase 2 part of the ongoing phase 2/3 study of litifilimab in people living with cutaneous lupus erythematosus (CLE).
The updated results, presented at the European Academy of Dermatology and Venereology (EADV) 2026 Congress in Vienna, Austria, represent the longest dataset reported for litifilimab in CLE and further support its potential to achieve rapid and durable improvements in skin disease activity.
In the study, participants treated with litifilimab in the double-blind, placebo-controlled period showed continued clinical improvements in skin disease activity through week 52. Notably, participants who switched from placebo to litifilimab treatment at week 24 experienced a rapid onset of treatment effect as early as four weeks.
Litifilimab is being evaluated as a potential once-monthly, first-in-class treatment designed to reduce inflammation at its source by selectively targeting blood dendritic cell antigen 2 (BDCA2) receptors on plasmacytoid dendritic cells (pDCs), which play a central role early in the inflammatory process in CLE.
In January 2026, litifilimab was granted beakthrough therapy Designation by the US Food and Drug Administration for the treatment of CLE.
