Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: 5 mg Serlopitant Tablets; Drug: Matching Placebo Tablets

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 72022
      • Study Site 221
  • California
    • Bakersfield, California, United States, 93301
      • Study Site 823
    • Fremont, California, United States, 94538
      • Study Site 204
    • Los Angeles, California, United States, 90045
      • Study Site 803
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Study Site 820
    • Denver, Colorado, United States, 80210
      • Study Site 804
  • Florida
    • Aventura, Florida, United States, 33180
      • Study Site 811
    • Jacksonville, Florida, United States, 32256
      • Study Site 801
    • Miami, Florida, United States, 33144
      • Study Site 331
    • Miami, Florida, United States, 33137
      • Study Site 807
    • Sarasota, Florida, United States, 34239
      • Study Site 824
    • West Palm Beach, Florida, United States, 33406
      • Study Site 818
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Study Site 349
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Study Site 814
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Study Site 808
  • Missouri
    • Rolla, Missouri, United States, 65401
      • Study Site 822
    • Saint Joseph, Missouri, United States, 64506
      • Study Site 371
    • Saint Louis, Missouri, United States, 63110
      • Study Site 817
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Study Site 821
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Study Site 813
    • Las Vegas, Nevada, United States, 89148
      • Study Site 387
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Study Site 816
    • Ocean Township, New Jersey, United States, 07712
      • Study site 121
  • New York
    • Bronx, New York, United States, 10458
      • Study Site 802
    • Brooklyn, New York, United States, 11203
      • Study Site 507
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Study Site 341
    • Raleigh, North Carolina, United States, 27612
      • Study Site 810
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Study Site 524
  • Oregon
    • Portland, Oregon, United States, 97202
      • Study Site 116
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Study Site 522
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Study Site 345
    • Warwick, Rhode Island, United States, 02886
      • Study Site 815
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Study Site 805
  • Texas
    • Austin, Texas, United States, 78745
      • Study Site 365
    • Dallas, Texas, United States, 75231
      • Study site 120
    • Fort Worth, Texas, United States, 76244
      • Study Site 819
    • Pflugerville, Texas, United States, 78660
      • Study Site 359
    • San Antonio, Texas, United States, 78229
      • Study Site 809
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Study Site 217
  • Washington
    • Spokane, Washington, United States, 99202
      • Study Site 806
    • Walla Walla, Washington, United States, 09362
      • Study Site 812

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

• Male or female, age 18 years or older at consent.
• The subject must have ongoing chronic pruritus
• The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.
• Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study.
• The pruritus must have been unresponsive to prior treatment with emollients.
• The subject's pruritus must be present on multiple segments of the body
• Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study
• All females who are of childbearing potential must be willing to practice highly effective contraception and not be pregnant or nursing
• Willing to comply with study visits and study related requirements including providing written informed consent.
• Adequate cognitive and physical ability, in the investigator's opinion, to comply with study visits and study related requirements including providing written informed consent

Exclusion

• Prior treatment with any NK1-receptor antagonists
• Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.
• Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.
• Use of an excluded therapy within 3 weeks prior to randomization
• Treatment with any investigational therapy within 3 weeks prior to randomization.
• Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.
• History of malignancy within 3 years prior to randomization, with the (actinic keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of skin).
• Any known major psychiatric diagnosis that would impact the subject's ability to complete the study
• Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.
• Known use of recreational drugs.
• Documented history of parasitic infection, including skin parasites such as scabies, within 12 weeks prior to randomization.
• Presence of clinically significant dementia, intellectual impairment, or any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
• History of hypersensitivity to serlopitant or any of its components.
• Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject's participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5 mg Serlopitant Tablets; Serlopitant Tablets	Drug: 5 mg Serlopitant Tablets; Serlopitant Tablets; Other Names: VPD-737
PLACEBO_COMPARATOR: 5 mg Placebo Tablets; Placebo Tablets	Drug: Matching Placebo Tablets; Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).	At Week 10
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).	At Weeks 2, 4, 6, and 8
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.	At Weeks 2, 4, 6, 8, and 10
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.	At Weeks 2, 4, 6, 8, and 10
Change From Baseline in Daily WI-NRS Scores Through Week 2	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.	Through 2 weeks
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10	The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.	At Weeks 2, 4, 6, and 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.	From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Plasma Concentrations of Serlopitant and Metabolites	The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.	At Week 10

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2019
• Primary Completion (ACTUAL): December 10, 2019
• Study Completion (ACTUAL): January 21, 2020

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurokinin-1 Receptor Antagonists; Serlopitant
• Other Study ID Numbers: MTI-117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No