Article Text
PDF
Abstract
Background Deucravacitinib is a first-in-class, oral, selective, allosteric 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 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.
Conclusions This phase 2 trial will characterize the efficacy, safety, and tolerability of deucravacitinib in patients with active DLE/SCLE.
Trial design
Primary and secondary endpoints assessed at week 16
References
Armstrong A, et al. J Am Acad Dermatol 2023;88(1):29–39.
Strober B, et al. J Am Acad Dermatol 2023;88(1):40–51.
Morand E, et al. Arthritis Rheumatol 2022 Nov 11 (Epub ahead of print).
Braunstein I, et al. Br J Dermatol 2012;166(5):971–975.
Burke JR, et al. Sci Transl Med 2019;11(502):eaaw1736.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.