View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
  2. Company News
September 19, 2018updated 12 Jul 2022 1:12pm

Menlo Therapeutics starts enrolment in Phase lll trial of serlopitant

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

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena