A Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the efficacy and safety of daxdilimab subcutaneous injection in reducing disease activity in adult participants with moderate-to-severe primary discoid lupus erythematosus.

Primary Discoid Lupus Erythematosus

Primary Efficacy: Mean change in CLASI-A score from Baseline (Day 1) to Week 24

Secondary Efficacy: Proportion of participants who achieve 0 or 1 on the CLA-IGA scale at Week 24 (5-point Likert scale [0-4])., Secondary Efficacy: Proportion of participants who achieve a ≥ 50% reduction in CLASI-A score from Baseline (Day 1) at Week 24., Secondary Efficacy: Mean change in the SADDLE from Baseline (Day 1) to Week 24., Pharmacokinetics and Immunogenicity: Serum concentration of daxdilimab over time., Pharmacokinetics and Immunogenicity: Incidence of ADA directed against daxdilimab over time., Safety: Incidence of TEAEs., Safety: Incidence of TESAEs, Safety: Incidence of TEAESIs: hypersensitivity reaction, including anaphylaxis, herpes zoster infection, serious (Grade 3 or higher) viral infection/reactivation, opportunistic infection, and malignancy (except non-melanoma skin cancer).

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