Serlopitant for psoriatic pruritus: A phase 2 randomized, double-blind, placebo-controlled clinical trial

David M. Pariser, Jerry Bagel, Mark Lebwohl, Gil Yosipovitch, Elaine Chien, Mary C. Spellman

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Background: Pruritus, a common symptom of psoriasis, negatively affects quality of life; however, treatment of lesional skin does not consistently alleviate psoriatic itch. Objective: To examine the effects of serlopitant, an oral, once-daily neurokinin 1 receptor antagonist, for treatment of psoriatic pruritus in a phase 2, randomized clinical trial (NCT03343639). Methods: Patients (n = 204) were randomized to receive serlopitant, 5 mg, or placebo daily for 8 weeks. Eligible adult patients had plaque psoriasis for ≥6 months, plaques covering ≤10% of body surface area, pruritus for ≥4 weeks, and Worst Itch Numeric Rating Scale (WI-NRS) score ≥7 at the initial screening. Results: Participants (54.2% women) had a mean age of 47.5 years and 85.2% were white. Mean baseline WI-NRS scores were 8.3 for serlopitant and 8.1 for placebo. The WI-NRS 4-point response rate at 8 weeks (primary end point) was 33.3% for serlopitant vs 21.1% for placebo (P = .028); at 4 weeks the rates were 20.8% for serlopitant vs 11.5% for placebo (P = .039). Treatment-related adverse events were reported for 4.9% of serlopitant-treated and 4.0% of placebo-treated patients. Limitations: This was a phase 2 study with a small study population. Patients with severe psoriasis were excluded. Conclusion: Serlopitant significantly reduced pruritus associated with mild to moderate psoriasis, supporting continued development of serlopitant for this patient population.

Original languageEnglish (US)
Pages (from-to)1314-1320
Number of pages7
JournalJournal of the American Academy of Dermatology
Volume82
Issue number6
DOIs
StatePublished - Jun 2020

Keywords

  • clinical trial
  • neurokinin 1 receptor (NKR)
  • pruritus
  • psoriasis
  • serlopitant
  • substance P

ASJC Scopus subject areas

  • Dermatology

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