Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis
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 subj...
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Elsevier
2024-02-01
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| Series: | Journal of Allergy and Clinical Immunology: Global |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772829323001200 |
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| author | Barbara Rewerska, MD Lawrence D. Sher, MD Sady Alpizar, MD Sylvia Pauser, MD Grazyna Pulka, MD Neelufar Mozaffarian, MD, PhD Yacine Salhi, PhD Camille Martinet, MS Wafaa Jabert, MS Girish Gudi, PhD Vinu CA, MPharm, MSc Sunitha GN, PhD Julie Macoin, MSc Victor Anstett, MS Riccardo Turrini, PhD Marie-Agnès Doucey, PhD Stanislas Blein, PhD Cyril Konto, MD Martina Machkova, MD |
| author_facet | Barbara Rewerska, MD Lawrence D. Sher, MD Sady Alpizar, MD Sylvia Pauser, MD Grazyna Pulka, MD Neelufar Mozaffarian, MD, PhD Yacine Salhi, PhD Camille Martinet, MS Wafaa Jabert, MS Girish Gudi, PhD Vinu CA, MPharm, MSc Sunitha GN, PhD Julie Macoin, MSc Victor Anstett, MS Riccardo Turrini, PhD Marie-Agnès Doucey, PhD Stanislas Blein, PhD Cyril Konto, MD Martina Machkova, MD |
| author_sort | Barbara Rewerska, MD |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T03:29:52Z |
| format | Article |
| id | doaj.art-f0ee145bd815434e8dd240eedfceb966 |
| institution | Directory Open Access Journal |
| issn | 2772-8293 |
| language | English |
| last_indexed | 2024-03-08T03:29:52Z |
| publishDate | 2024-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Allergy and Clinical Immunology: Global |
| spelling | doaj.art-f0ee145bd815434e8dd240eedfceb9662024-02-11T05:13:08ZengElsevierJournal of Allergy and Clinical Immunology: Global2772-82932024-02-0131100195Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitisBarbara Rewerska, MD0Lawrence D. Sher, MD1Sady Alpizar, MD2Sylvia Pauser, MD3Grazyna Pulka, MD4Neelufar Mozaffarian, MD, PhD5Yacine Salhi, PhD6Camille Martinet, MS7Wafaa Jabert, MS8Girish Gudi, PhD9Vinu CA, MPharm, MSc10Sunitha GN, PhD11Julie Macoin, MSc12Victor Anstett, MS13Riccardo Turrini, PhD14Marie-Agnès Doucey, PhD15Stanislas Blein, PhD16Cyril Konto, MD17Martina Machkova, MD18Diamond Clinic, Krakow, PolandPeninsula Research Associates, Rolling Hills Estates, CalifClinical Research Trials of Florida Inc, Tampa, FlaKliFOs—Klinische Forschung Osnabrück, Osnabrück, GermanySchool of Medicine, Jagiellonian University Medical College, Krakow, PolandIchnos Sciences, New York, NYIchnos Sciences, New York, NYKeyrus Life Science, Levallois-Perret, FranceIchnos Sciences, New York, NYIchnos Sciences, New York, NYIchnos Sciences, New York, NYGlenmark Pharmaceuticals, Mumbai, IndiaIchnos Sciences, New York, NYIchnos Sciences, New York, NYIchnos Sciences, New York, NYIchnos Sciences, New York, NYIchnos Sciences, New York, NYIchnos Sciences, New York, NY; Corresponding author: Cyril Konto, MD, Ichnos Sciences Inc, One World Trade Center, 76th Floor, Suite D, New York, NY 10007.CCR Prague sro, Prague, Czech RepublicBackground: 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.http://www.sciencedirect.com/science/article/pii/S2772829323001200Atopic dermatitisanti-OX40 receptorhumanized monoclonal antibodyphase 2telazorlimab |
| spellingShingle | Barbara Rewerska, MD Lawrence D. Sher, MD Sady Alpizar, MD Sylvia Pauser, MD Grazyna Pulka, MD Neelufar Mozaffarian, MD, PhD Yacine Salhi, PhD Camille Martinet, MS Wafaa Jabert, MS Girish Gudi, PhD Vinu CA, MPharm, MSc Sunitha GN, PhD Julie Macoin, MSc Victor Anstett, MS Riccardo Turrini, PhD Marie-Agnès Doucey, PhD Stanislas Blein, PhD Cyril Konto, MD Martina Machkova, MD Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis Journal of Allergy and Clinical Immunology: Global Atopic dermatitis anti-OX40 receptor humanized monoclonal antibody phase 2 telazorlimab |
| title | Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis |
| title_full | Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis |
| title_fullStr | Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis |
| title_full_unstemmed | Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis |
| title_short | Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis |
| title_sort | phase 2b randomized trial of ox40 inhibitor telazorlimab for moderate to severe atopic dermatitis |
| topic | Atopic dermatitis anti-OX40 receptor humanized monoclonal antibody phase 2 telazorlimab |
| url | http://www.sciencedirect.com/science/article/pii/S2772829323001200 |
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