Phase 2 DLE Trial Meets Primary Endpoint With Daxdilimab
Key Takeaways
- New data presented at EADV 2026 show reductions in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) scores in patients with moderate-to-severe, treatment-refractory discoid lupus erythematosus (DLE) when treated with daxdilimab.
- Approximately 62% of patients receiving either daxdilimab dose achieved at least a 50% reduction in CLASI-A score (CLASI-50), compared with 23.7% receiving placebo.
- No serious adverse events or deaths were reported through week 24; treatment-related adverse event rates were similar across the daxdilimab and placebo groups.
Daxdilimab improved measures of disease activity in adults with moderate-to-severe discoid lupus erythematosus (DLE), according to new data from a phase 2 trial presented at EADV 2026.
Researchers included 72 adults aged 18 to 75 years with chronic, treatment-refractory DLE lasting at least 6 months, a baseline Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score of 8 or higher, and no systemic features. Patients received low-dose daxdilimab (n = 24), high-dose daxdilimab (n = 23), or placebo (n = 25) every 4 weeks through week 20.
Daxdilimab Improved CLASI-A and DLE Response Rates
At week 24, the least-squares mean difference in CLASI-A change versus placebo was −6.0 with low-dose daxdilimab (90% CI, −8.7 to −3.2; P = 0.0005) and −5.7 with high-dose treatment (90% CI, −8.5 to −2.9; P = 0.0012). Responses were evident by week 4.
Adjusted CLASI-50 response rates at week 24 were 61.7% with low-dose daxdilimab and 62.1% with high-dose treatment versus 23.7% with placebo. Cutaneous Lupus Activity Investigator's Global Assessment scores of 0 or 1 were achieved by 60.3%, 51.6%, and 8.9%, respectively.
Treatment-related adverse events occurred in 58.3% of the low-dose group, 56.5% of the high-dose group, and 60.0% of the placebo group. One high-dose recipient discontinued because of arthralgia. No serious adverse events were observed.
“Daxdilimab demonstrated significant improvement in the primary endpoint of CLASI-A and consistent efficacy across secondary endpoints, with a favourable safety profile in patients with moderate-to-severe DLE,” the authors wrote. “These findings support the role of pDCs in disease pathogenesis of DLE and the potential of targeting this pathway.”
Source
Werth V, et al. Abstract LB-136. Presented at EADV 2026.