472 Telazorlimab in atopic dermatitis: Phase 2b study shows improvement at 16 weeks

Telazorlimab, a monoclonal antibody to human OX40 costimulatory receptor on activated T cells, is being developed to treat autoimmune diseases. Herein, we describe topline results of a randomized, multinational, double-blind, placebo-controlled, phase 2b study that investigated the efficacy, safety, pharmacokinetics, and pharmacodynamics of different subcutaneous regimens of telazorlimab for patients with moderate-to-severe atopic dermatitis (AD). Part 1 randomized 313 adults (1:1:1:1): telazorlimab 300 mg every 2 weeks (q2w), 300 mg q4w, 75 mg q4w, or placebo. Part 2 randomized 149 adults (1:1): telazorlimab 600 mg q2w or placebo. All subjects received a loading dose of blinded telazorlimab or placebo at baseline, per their treatment group. The primary endpoint, percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 16, was met by the highest dose of telazorlimab in Part 1 and in Part 2 (p=0.008 vs placebo for both). A numerical trend for improvements in key secondary endpoints (Investigator’s Global Assessment 0-1, EASI-75) was observed. There were no safety signals in Part 1 or 2. Treatment-emergent adverse events (TEAEs) were comparable for telazorlimab vs placebo in Part 1 (65.4% vs 72.5%) and Part 2 (65.3% vs 50.0%). The most commonly reported TEAEs were AD, nasopharyngitis, upper respiratory tract infections, and headache. Serious AE rates were comparable for telazorlimab vs placebo (Part 1: 3.0% vs 1.3%; Part 2: 1.3% vs 0%, respectively). In conclusion, telazorlimab improved clinical signs and symptoms of moderate-to-severe AD, with a favorable safety and tolerability profile. Further evaluation of telazorlimab in the treatment of autoimmune disease is warranted.