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Area of Science:

  • Dermatology
  • Immunology
  • Pharmacology

Background:

  • Plaque psoriasis affecting high-impact sites presents significant treatment challenges.
  • Icotrokinra, an oral peptide targeting interleukin-23 receptors, is under investigation for this condition.

Purpose of the Study:

  • To evaluate the efficacy and safety of icotrokinra in patients with plaque psoriasis involving high-impact sites.

Main Methods:

  • A phase 3, double-blind, placebo-controlled trial randomized 311 participants (≥12 years) with plaque psoriasis to icotrokinra (200 mg daily) or placebo (2:1 ratio).
  • The primary endpoint was the proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at 16 weeks.
  • Secondary endpoints included clearance of psoriasis on scalp, genitalia, hands, and feet.

Main Results:

  • 56.7% of icotrokinra recipients achieved IGA 0 or 1 versus 5.8% for placebo (P<0.001).
  • Significant improvements were observed for scalp (65.9% vs 10.6%) and genital (76.5% vs 21.4%) psoriasis with icotrokinra.
  • No significant difference was found for hand and foot psoriasis (41.7% vs 26.1%).
  • Adverse events were reported in 50% of icotrokinra users and 42% of placebo users.

Conclusions:

  • Icotrokinra demonstrated significant efficacy in treating plaque psoriasis on the overall skin, scalp, and genital areas at 16 weeks.
  • The treatment did not show significant efficacy for psoriasis affecting hands and feet.
  • No safety concerns were identified during the study period.