STUDY DESIGNS

POETYK PSO‑1 and POETYK PSO‑2

Possible plaque psoriasis patient looking over shoulder

PSO-1 and PSO-21-4

Sotyktu POETYK PSO-1 Clinical Trial Design
Sotyktu POETYK PSO-2 Clinical Trial Design

STUDY DESIGN1

Key eligibility criteria

  • Adults with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy
  • PASI ≥12, sPGA ≥3, BSA involvement ≥10%

Co-primary endpoints

  • Proportion of patients who achieved the following responses vs placebo at Week 16:
    • At least a 75% improvement in PASI scores from baseline (PASI 75)
    • sPGA score of 0 (clear) or 1 (almost clear)

Select key secondary endpoints

  • Proportion of patients who achieved the following responses vs apremilast:
    • At Week 16 and Week 24: PASI 75, PASI 90
    • At Week 16: ss-PGA score of 0 (clear) or 1 (almost clear)
  • Proportion of patients who achieved the following responses vs placebo
    • At Week 16: ss-PGA score of 0 (clear) or 1 (almost clear)
  • Statistical significance was not met for the following key secondary endpoints1,2,3
    • PGA-F 0/1 (PGA-F score of clear or minimal disease) vs placebo (BL ≥3) at Week 16, PSSD symptom score of 0 vs apremilast (BL ≥1) at Week 16

BID=twice daily; BL=baseline; BSA=body surface area; PASI 50=≥50% reduction from baseline in PASI; PASI 75=≥75% reduction from baseline PASI; PASI 90=≥90% reduction from baseline PASI; QD=once daily; sPGA=static Physician's Global Assessment; ss-PGA=scalp-specific Physician's Global Assessment; PGA-F=Physician's Global Assessment of Fingernail Psoriasis; PSSD=Psoriasis Symptoms and Signs Diary.

POETYK PSO-LTE:

Long-term extension study1-6

Phase 3 and long-term extension (LTE) study of Sotyktu in POETYK PSO-1 and PSO-2 clinical trials
* Safety and efficacy data through 256 weeks with a cutoff date of September 2, 2024.5

STUDY DESIGN

  • Patients who completed treatment through Week 52 in either POETYK PSO-1 or PSO-2 were eligible to enroll in an optional LTE and be switched to open-label SOTYKTU 6 mg once daily4
  • A total of 1519 patients received ≥1 dose of SOTYKTU across the parent trials and the LTE including 1364 patients in PSO-1/PSO-2 and 1221 patients in the LTE4
  • Exposure during Weeks 0-52 of PSO-1/PSO-2 was 969.0 PY, with an additional 4077.7 PY of exposure during the LTE5,6
  • 1206 (79.4%) patients had ≥12 months of total SOTYKTU exposure and 449 (29.6%) patients had ≥60 months of total SOTYKTU exposure throughout POETYK PSO-1, PSO-2, and PSO-LTE5

LTE=long-term extension; PY=patient-years.

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References:
  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 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. J Am Acad Dermatol. 2023;88(1):29-39.
  3. 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 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40-51.
  4. Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase 3 POETYK trials. Br J Dermatol. 2024;190:668-679.
  5. Armstrong AW, Warren R, Strober B, et al. Deucravacitinib in moderate to severe plaque psoriasis: 5-year, long-term safety and clinical and patient-reported efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials. Presented at the Winter Clinical Dermatology Conference; February 14-19, 2025; Waikoloa, HI.
  6. ClinicalTrials.gov. NCT04036435. https://clinicaltrials.gov/ct2/show/NCT04036435. Accessed June 8, 2023.


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