Menlo Therapeutics starts enrolment in Phase lll trial of serlopitant

19th September 2018 (Last Updated September 19th, 2018 00:00)

Menlo Therapeutics has begun patient enrolment in the second of two Phase lll trials of serlopitant for the treatment of pruritus with prurigo nodularis (PN).

Menlo Therapeutics starts enrolment in Phase lll trial of serlopitant
The large scaly patch on the left is due to scratching. Credit: Michael Geary.

Menlo Therapeutics has begun patient enrolment in the second of two Phase lll trials of serlopitant for the treatment of pruritus with prurigo nodularis (PN).

The multi-centre, randomised, double-blind, placebo-controlled trial is being conducted in Europe.

The trial aims to determine whether the 5mg daily dose of serlopitant, administered for ten weeks, can minimise pruritus associated with PN compared with placebo.

It is expected to enrol nearly 200 patients with a worst-itch NRS score, or WI-NRS, of at least seven at screening at around 50 sites.

The trial’s primary efficacy endpoint is a four-point responder rate in the WI-NRS at ten weeks.

Results from the trial are expected to be available in the first half of 2020.

Menlo Therapeutics is currently conducting the first of two PN Phase lll trials in the US.

The trial, which started enrolling patients in May this year, features a similar design to the second PN Phase lll trial.

"The most common descriptions of pruritus reported by these patients at baseline were itching, combined with pain-related sensations such as burning and stinging."

In addition, Menlo Therapeutics completed a Phase ll clinical trial of serlopitant in patients with PN in June 2016.

Germany’s University Hospital Münster Department of Dermatology Center for Chronic Pruritus representative Dr Sonja Ständer recently presented a new exploratory analysis of additional data from the Phase ll trial.

Ständer said: “Limited data are available about disease characteristics for patients with prurigo nodularis. The Phase ll trial of serlopitant was one of the largest randomised controlled trials conducted to date in this patient population, and we wanted to conduct a retrospective analysis to better understand the sensory experience of patients with PN and the impact of treatment on these sensations.

“The most common descriptions of pruritus reported by these patients at baseline were itching, combined with pain-related sensations such as burning and stinging.

“In this retrospective analysis, we observed improvement in some of the most common pruritus characteristics reported by the patients in this study when treated with serlopitant for eight weeks.”

Pruritus or itch is a sensation that leads to the desire or reflex to scratch.