Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis.
| Autor: | Rewerska B; Diamond Clinic, Krakow, Poland., Sher LD; Peninsula Research Associates, Rolling Hills Estates, Calif., Alpizar S; Clinical Research Trials of Florida Inc, Tampa, Fla., Pauser S; KliFOs-Klinische Forschung Osnabrück, Osnabrück, Germany., Pulka G; School of Medicine, Jagiellonian University Medical College, Krakow, Poland., Mozaffarian N; Ichnos Sciences, New York, NY., Salhi Y; Ichnos Sciences, New York, NY., Martinet C; Keyrus Life Science, Levallois-Perret, France., Jabert W; Ichnos Sciences, New York, NY., Gudi G; Ichnos Sciences, New York, NY., Ca V; Ichnos Sciences, New York, NY., Gn S; Glenmark Pharmaceuticals, Mumbai, India., Macoin J; Ichnos Sciences, New York, NY., Anstett V; Ichnos Sciences, New York, NY., Turrini R; Ichnos Sciences, New York, NY., Doucey MA; Ichnos Sciences, New York, NY., Blein S; Ichnos Sciences, New York, NY., Konto C; Ichnos Sciences, New York, NY., Machkova M; CCR Prague sro, Prague, Czech Republic. |
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| Jazyk: | angličtina |
| Zdroj: | The journal of allergy and clinical immunology. Global [J Allergy Clin Immunol Glob] 2023 Nov 22; Vol. 3 (1), pp. 100195. Date of Electronic Publication: 2023 Nov 22 (Print Publication: 2024). |
| DOI: | 10.1016/j.jacig.2023.100195 |
| Abstrakt: | Background: Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell-mediated diseases. Objective: This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis. Methods: 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. Results: 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. Conclusion: 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. Competing Interests: Supported by Ichnos Sciences (previously Glenmark Pharmaceuticals SA). The sponsor participated in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. Disclosure of potential conflict of interest: B. Rewerska, L. D. Sher, S. Alpizar, S. Pauser, G. Pulka, and M. Machkova have received research funding as principal investigators from Ichnos Sciences. V. CA, J. Macoin, V. Anstett, R. Turrini, and C. Konto are current employees of Ichnos Sciences. S. GN is a current employee of Glenmark Pharmaceuticals. N. Mozaffarian, Y. Salhi, W. Jabert, G. Gudi, S. Blein, and M.-A. Doucey are former employees of Ichnos Sciences (formerly Glenmark Pharmaceuticals). C. Martinet is an employee of Keyrus, a contractor for Ichnos Sciences. (© 2023 The Author(s).) |
| Databáze: | MEDLINE |
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