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LP-179 Design of 2 phase 3, double-blind, placebo-controlled, global trials of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with active systemic lupus erythematosus
  1. Cristina Arriens1,2,
  2. Anca Askanase3,
  3. Richard Furie4,
  4. Eric Morand5,
  5. Ronald van Vollenhoven6,
  6. Kevin Connors7,
  7. Monica Davey7,
  8. Nikolay Delev7,
  9. Vaishali Shah7,
  10. Anna Stevens7,
  11. Thomas Wegman7 and
  12. Coburn Hobar7
  1. 1Arthritis and Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation, USA
  2. 2Medicine, University of Oklahoma Health Sciences Center, USA
  3. 3Rheumatology, Columbia University, USA
  4. 4Rheumatology, Northwell Health, USA
  5. 5School of Clinical Sciences, Monash University, Australia
  6. 6Clinical Immunology and Rheumatology, Amsterdam University Medical Centers, Netherlands
  7. 7Clinical Development, Bristol Myers Squibb, USA


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 the primary endpoint and all key secondary endpoints in a phase 2 trial in patients with systemic lupus erythematosus (SLE).³ Here, we describe 2 phase 3 trials currently underway to assess the efficacy and safety of deucravacitinib in patients with active SLE. These phase 3 trials have been designed to replicate the successful elements of the phase 2 trial, including its glucocorticoid-tapering strategy and rigorous management structure.³

Methods In these phase 3, randomized, double-blind, placebo-controlled, global trials (POETYK SLE-1 [NCT05617677], POETYK SLE-2 [NCT05620407]), adults (aged 18–75) with active SLE on background standard-of-care treatment will be randomized (1:1) to placebo or deucravacitinib for 52 weeks of double-blind treatment (figure 1). Patients on glucocorticoids will be instructed to taper, unless significant disease activity is present, to a threshold dose level during the double-blind treatment period. At week 52, patients may choose to continue in a 104-week open-label extension phase, in which all patients receive deucravacitinib. Key eligibility criteria and study design are depicted below (figure 1) rimary endpoint of SLE Responder Index (SRI[4]) and all secondary endpoints will be assessed at week 52 (table 1) safety and tolerability will be assessed throughout the trial

Results Planned randomization in each trial includes 490 patients (245 per treatment group) in 27 countries across North and South America, Europe, and Asia-Pacific.

Conclusions The phase 3 POETYK SLE trials will further evaluate the efficacy and safety of deucravacitinib, an oral, selective, TYK2 inhibitor, in patients with active SLE.

Abstract LP-179 Figure 1

POETYK SLE-1 and POETYK SLE-2 Trial Design

Abstract LP-179 Table 1

Primary and Secondary Endpoints Assessed at Week 52


  1. Armstrong A, et al. J Am Acad Dermatol 2022;S0190-9622(22)02256-3.

  2. Strober B, et al. J Am Acad Dermatol 2022;S0190-9622(22)02643-3.

  3. Morand E, et al. Arthritis Rheumatol 2022;Nov 11 (Epub ahead of print). doi: 10.1002/art.42391.

  • Systemic Lupus Erythematosus
  • Clinical Trial
  • TYK2

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