PO:11:280 Randomized, placebo-controlled, double-blind phase 1b/2 study to explore safety, pharmacokinetics, and initial efficacy of DS-7011a, an anti-toll-like receptor 7 monoclonal antibody, in SLE patients

Objectives Toll-like receptor (TLR)7 is a pattern recognition receptor that contributes to SLE pathogenesis.DS-7011a is an anti-TLR7 monoclonal antibody (mAb) that inhibits TLR7 signaling.The aim of this study was to explore safety and PK and to detect initial efficacy of DS-7011a in SLE patients.Methods This was a randomized, placebo-controlled, double-blind Phase 1b/2 study [NCT05638802].Patients were: 1) globally enrolled and randomized 2:1 to DS-7011a or placebo; 2) required to have definite SLE according to the 2019 EULAR/ ACR criteria, active CLE (CLASI-A score of at least 4), and no or inactive LN; 3) given DS-7011a (20 mg/kg) or placebo IV 3 times Q4W starting at Week 0; and 4) followed until Week 16 to assess treatment effect.Study primary objective was safety and secondary objectives were PK and initial efficacy.