STUDY DESIGNS

POETYK PSO-1 Study Design

52-week, double-blind, placebo- and active comparator-controlled study in moderate-to-severe plaque psoriasis1-3

Adapted from Product Monograph and Armstrong et al., 2022.

    Co-primary endpoints1
  • % patients who achieved PASI 75 vs. placebo at Week 16
  • % patients who achieved a sPGA score of 0 (clear) or 1 (almost clear) vs. placebo at Week 16
    Secondary endpoints1
  • % patients who achieved PASI 90, PASI 100, sPGA 0, ss-PGA (scalp) score of 0 (clear) or 1 (almost clear) vs.
    placebo at Week 16
  • % patients who achieved PASI 75, PASI 90, and sPGA 0/1 vs. apremilast at Weeks 16 and 24
  • % patients who achieved sPGA 0 and ss-PGA 0/1 vs. apremilast at Week 16
    Key inclusion criteria1,2
  • ≥18 years of age
  • Moderate-to-severe plaque psoriasis
  • Eligible for systemic therapy or phototherapy
  • BSA involvement ≥10%
  • PASI score ≥12
  • sPGA ≥3 (moderate or severe) on a 5-point scale of overall disease severity
    Key exclusion criteria3
  • Has non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis)
    at screening or Day 1
  • History or evidence of outpatient active infection and/or febrile illness within 7 days before Day 1
  • Prior exposure to SOTYKTU or active comparator

POETYK PSO-2 Study Design

52-week, double-blind, placebo- and active comparator-controlled study
in moderate-to-severe plaque psoriasis1,4

Adapted from Product Monograph and Strober et al., 2022.

    Co-primary endpoints1
  • % patients who achieved PASI 75 vs. placebo at Week 16
  • % patients who achieved a sPGA score of 0 (clear) or 1 (almost clear) vs. placebo at Week 16
    Secondary endpoints1
  • % patients who achieved PASI 90, PASI 100, sPGA 0, ss-PGA (scalp) score of 0 (clear) or 1 (almost clear) vs.
    placebo at Week 16
  • % patients who achieved PASI 75, PASI 90, and sPGA 0/1 vs. apremilast at Weeks 16 and 24
  • % patients who achieved sPGA 0 and ss-PGA 0/1 vs. apremilast at Week 16
    Key inclusion criteria1,4
  • ≥18 years of age
  • Moderate-to-severe plaque psoriasis
  • Eligible for systemic therapy or phototherapy
  • BSA involvement ≥10%
  • PASI score ≥12
  • sPGA ≥3 (moderate or severe) on a 5-point scale of overall disease severity
    Key exclusion criteria4,5
  • Has non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis)
    at screening or Day 1
  • History or evidence of outpatient active infection and/or febrile illness within 7 days before Day 1
  • Prior exposure to SOTYKTU or active comparator

Selected baseline characteristics across POETYK PSO-1 and -21

BID=twice daily; BSA=body surface area; DLQI=Dermatology Life Quality Index; IL=interleukin; PASI=Psoriasis Area and Severity Index; PSSD=Psoriasis Symptoms and Signs Diary;
QD=once daily; sPGA=static Physician’s Global Assessment; ss-PGA=scalp severity Physician’s Global Assessment; TNF=tumour necrosis factor
References:
1. SOTYKTU Product Monograph. Bristol-Myers Squibb Canada Co. November 23, 2022. 2. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast
in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. JAAD. 2022. doi: 10.1016/j.jaad.2022.07.002 3. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. JAAD. 2022. doi: 10.1016/j.jaad.2022.07.002 Suppl 4. Strober B, Thaçi D, Sofen H,
et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 POETYK PSO-2
trial. JAAD. 2022. doi: 10.1016/j.jaad.2022.08.061 5. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis:
efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 POETYK PSO-2 trial. JAAD. 2022. doi: 10.1016/j.jaad.2022.08.061 Suppl

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