Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis

• Published in: The journal of allergy and clinical immunology. Global 2024-02, Vol.3 (1), p.100195-100195, Article 100195
• Main Authors: Rewerska, Barbara, Sher, Lawrence D., Alpizar, Sady, Pauser, Sylvia, Pulka, Grazyna, Mozaffarian, Neelufar, Salhi, Yacine, Martinet, Camille, Jabert, Wafaa, Gudi, Girish, CA, Vinu, GN, Sunitha, Macoin, Julie, Anstett, Victor, Turrini, Riccardo, Doucey, Marie-Agnès, Blein, Stanislas, Konto, Cyril, Machkova, Martina
• Format: Article
• Language: English
• Subjects: anti-OX40 receptor; Atopic dermatitis; humanized monoclonal antibody; phase 2; telazorlimab
• ISSN: 2772-8293; 2772-8293
• DOI: 10.1016/j.jacig.2023.100195

Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell–mediated diseases. This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis. In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks’ blinded treatment, followed by 38 weeks’ open-label treatment and 12 weeks’ drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events. The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (−54.4% vs −34.2% for part 1 and −59.0% vs −41.8% for part 2, P = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2. Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis.