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• W4379795020 abstract "Background Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of adults with plaque psoriasis [1,2] . Deucravacitinib demonstrated efficacy across multiple outcome measures, including achievement of ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity score (CLASI-50), in a phase 2 trial in patients with systemic lupus erythematosus (SLE) [3] and is being investigated in two phase 3 trials ( NCT05617677 ; NCT05620407 ). Patients with discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE) have elevated expression of Type I interferons (IFN) [4] . Deucravacitinib mediates signaling of Type I IFN, IL-12, and IL-23 and may be an effective treatment for patients with DLE/SCLE [5] . Objectives Results of this ongoing phase 2 trial ( NCT04857034 ) will characterize the efficacy and safety of deucravacitinib compared with placebo in patients with active DLE/SCLE with or without SLE. Methods This phase 2, global, randomized, double-blind, placebo-controlled trial is enrolling adults (aged 18-75) with biopsy-confirmed clinical diagnosis of DLE/SCLE. Key eligibility criteria and study design are depicted below ( Figure 1 ). Eligible patients will be randomized (1:1:1) to treatment with placebo or deucravacitinib (dose 1 or 2) for 16 weeks. At week 16, all patients randomized to placebo will be rerandomized (1:1) to treatment with deucravacitinib dose 1 or 2 until week 52. Patients originally randomized to deucravacitinib will continue treatment until week 52. The primary and secondary endpoints are depicted below ( Table 1 ). This trial will also assess the safety and tolerability of 2 doses of deucravacitinib, exploratory efficacy endpoints, patient-reported outcomes, and pharmacodynamics. Results Planned enrollment is 75 total patients (25 per double-blind treatment group) in 8 countries in North and South America, Europe, and Asia-Pacific regions. Conclusion This phase 2 trial will characterize the efficacy, safety, and tolerability of deucravacitinib in patients with active DLE/SCLE. References [1]Armstrong A, et al. J Am Acad Dermatol . 2023;88(1):29-39. [2]Strober B, et al. J Am Acad Dermatol . 2023;88(1):40-51. [3]Morand E, et al. Arthritis Rheumatol. 2022 Nov 11 (Epub ahead of print). [4]Braunstein I, et al. Br J Dermatol . 2012;166(5):971-975. [5]Burke JR, et al. Sci Transl Med . 2019;11(502):eaaw1736. Table 1. Primary and Secondary Endpoints Assessed at Week 16 Primary Endpoint • Mean percentage change from baseline in CLASI-A score Secondary Endpoints • Percentage of patients who achieve a ≥ 50% reduction in CLASI-A score (CLASI-50) from baseline • Percentage of patients who achieve a ≥ 4-point improvement in CLASI-A from baseline • Mean change from baseline in CLASI-A score • Percentage of patients who achieve a complete response (defined as a CLASI-A score of 0) CLASI-A, Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity. Acknowledgements This study was sponsored by Bristol Myers Squibb. Disclosure of Interests Victoria P. Werth Consultant of: Celgene, Medimmune, Resolve, Genentech, Idera, Janssen, Lilly, Biogen, Bristol Myers Squibb, Gilead, Amgen, Medscape, Nektar, Incyte, EMD Serono, CSL Behring, Principia, Crisalis, Viela Bio, Argenx, Kirin, AstraZeneca, AbbVie, GSK, Cugene, UCB, Corcept, and Beacon Bioscience, Grant/research support from: Celgene, Janssen, Biogen, Gilead, AstraZeneca, Viela, Amgen, and Lupus Research Alliance/BMS, Joseph F. Merola Consultant of: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB., Jörg Wenzel Consultant of: GSK, Incyte, Spirig, AstraZeneca, Bristol Myers Squibb, Medac, Biogen, Novartis, LEO, Kyowa Kirin, Janssen, Bayer, Merck/Serono, Roche, Pfizer, ArrayBio, and Amgen, Nikolay Delev Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Harini Kothari Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Richard Meier Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Shalabh Singhal Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Malavi Madireddi Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Shimon Korish Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb." @default.
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• W4379795020 date "2023-05-30" @default.
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• W4379795020 title "AB0609 DESIGN OF A PHASE 2, DOUBLE-BLIND, PLACEBO-CONTROLLED, GLOBAL TRIAL OF DEUCRAVACITINIB, AN ORAL, SELECTIVE, ALLOSTERIC TYROSINE KINASE 2 (TYK2) INHIBITOR, IN PATIENTS WITH ACTIVE DISCOID AND/OR SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS" @default.
• W4379795020 doi "https://doi.org/10.1136/annrheumdis-2023-eular.1712" @default.
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