Approximately 99 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously over 48 weeks. After week 24 all subjects will be receiving daxbilimab, including those assigned to the placebo arm, for the remainder of the 48 week treatment period. The maximum trial duration per participant is approximately 60 weeks including screening, the 48 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severely active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.