Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial

Gil Yosipovitch, Sonja Ständer, Matthew B. Kerby, James W. Larrick, Andrew J. Perlman, Edward F. Schnipper, Xiaoming Zhang, Jean Y. Tang, Thomas Luger, Martin Steinhoff

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Background: The substance P/neurokinin 1 receptor pathway is critical in chronic pruritus; anecdotal evidence suggests that antagonism of this pathway can reduce chronic itch. Objective: To assess the safety and efficacy of the substance P/neurokinin 1 receptor antagonist serlopitant in treating chronic pruritus. Methods: Eligible patients with severe chronic pruritus who were refractory to antihistamines or topical steroids were randomized to serlopitant, 0.25, 1, or 5 mg, or to placebo, administered once daily for 6 weeks as monotherapy or with midpotency steroids and emollients. The primary efficacy end point was percentage change in visual analog scale pruritus score from baseline. Results: Serlopitant treatment resulted in a dose-dependent decrease in pruritus. The mean percentage decreases from baseline visual analog scale pruritus scores were statistically significantly larger with the 1- and 5-mg doses of serlopitant (P =.022 and P =.013, respectively) than with placebo at week 6. No significant safety or tolerability differences were detected among the groups. Limitations: The sample size was insufficient for subgroup analyses of the efficacy of serlopitant for chronic pruritus on the basis of underlying conditions. Conclusions: Serlopitant, 1 mg and 5 mg daily, was associated with a statistically significant reduction in chronic pruritus and was well tolerated (NCT01951274).

Original languageEnglish (US)
Pages (from-to)882-891.e10
JournalJournal of the American Academy of Dermatology
Volume78
Issue number5
DOIs
StatePublished - May 1 2018

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Pruritus
Placebos
Clinical Trials
Therapeutics
Substance P
Visual Analog Scale
Steroids
Neurokinin-1 Receptor Antagonists
Emollients
Safety
Neurokinin-1 Receptors
Critical Pathways
serlopitant
Histamine Antagonists
Sample Size

Keywords

  • chronic pruritus
  • itch
  • neurokinin 1 receptor
  • NK1 receptor
  • NK1 receptor antagonist
  • serlopitant
  • substance P

ASJC Scopus subject areas

  • Dermatology

Cite this

Serlopitant for the treatment of chronic pruritus : Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. / Yosipovitch, Gil; Ständer, Sonja; Kerby, Matthew B.; Larrick, James W.; Perlman, Andrew J.; Schnipper, Edward F.; Zhang, Xiaoming; Tang, Jean Y.; Luger, Thomas; Steinhoff, Martin.

In: Journal of the American Academy of Dermatology, Vol. 78, No. 5, 01.05.2018, p. 882-891.e10.

Research output: Contribution to journalArticle

Yosipovitch, G, Ständer, S, Kerby, MB, Larrick, JW, Perlman, AJ, Schnipper, EF, Zhang, X, Tang, JY, Luger, T & Steinhoff, M 2018, 'Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial', Journal of the American Academy of Dermatology, vol. 78, no. 5, pp. 882-891.e10. https://doi.org/10.1016/j.jaad.2018.02.030
Yosipovitch, Gil ; Ständer, Sonja ; Kerby, Matthew B. ; Larrick, James W. ; Perlman, Andrew J. ; Schnipper, Edward F. ; Zhang, Xiaoming ; Tang, Jean Y. ; Luger, Thomas ; Steinhoff, Martin. / Serlopitant for the treatment of chronic pruritus : Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. In: Journal of the American Academy of Dermatology. 2018 ; Vol. 78, No. 5. pp. 882-891.e10.
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