Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Study Site 504
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Study Site 533
  • California
    • Fremont, California, United States, 94538
      • Study Site 204
    • North Hollywood, California, United States, 91606
      • Study Site 383
    • San Diego, California, United States, 92108
      • Study Site 356
    • Santa Ana, California, United States, 92701
      • Study Site 514
  • Florida
    • Aventura, Florida, United States, 33180
      • Study Site 501
    • Coral Gables, Florida, United States, 33134
      • Study Site 210
    • Fort Lauderdale, Florida, United States, 33316
      • Study Site 534
    • Miami, Florida, United States, 33155
      • Study Site 531
    • Miami, Florida, United States, 33165
      • Study Site 530
    • North Miami Beach, Florida, United States, 33162
      • Study Site 222
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Study Site 510
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Study Site 388
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Study Site 228
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Study Site 527
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Study Site 525
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Study Site 379
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Study Site 506
    • Detroit, Michigan, United States, 48202
      • Study Site 515
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Study Site 371
    • Saint Louis, Missouri, United States, 63110
      • Study Site 528
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Study Site 227
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Study Site 526
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Study Site 201
    • Verona, New Jersey, United States, 07044-2946
      • Study Site 529
  • New York
    • Brooklyn, New York, United States, 11203
      • Study Site 507
    • Buffalo, New York, United States, 14221
      • Study Site 508
    • New York, New York, United States, 10025
      • Study Site 500
    • New York, New York, United States, 10075
      • Study Site 517
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Study Site 341
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Study Site 516
    • Cleveland, Ohio, United States, 44106
      • Study Site 509
    • Dublin, Ohio, United States, 43016
      • Study Site 524
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Study site 112
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Study Site 523
    • Pittsburgh, Pennsylvania, United States, 15213
      • Study Site 522
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Study Site 345
  • Tennessee
    • Knoxville, Tennessee, United States, 37317
      • Study Site 511
    • Nashville, Tennessee, United States, 37215
      • Study Site 805
  • Texas
    • Austin, Texas, United States, 78745
      • Study Site 365
    • Bellaire, Texas, United States, 77401
      • Study Site 520
    • Dallas, Texas, United States, 75231
      • Study Site 502
    • Houston, Texas, United States, 77004
      • Study Site 224
    • Pflugerville, Texas, United States, 78660
      • Study Site 359
    • San Antonio, Texas, United States, 78213
      • Study Site 361
    • Webster, Texas, United States, 77598
      • Study Site 226
  • Washington
    • Spokane, Washington, United States, 99202
      • Study Site 806
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Study Site 532

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (Subjects must meet the following criteria to be randomized into the study:

1. Male or female, age 18 years or older at consent.
2. Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas.
3. Idiopathic PN, or an identified pruritic condition associated with the PN with persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition.
4. The worst pruritus is identified as within the areas of the PN lesions, with a 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.
5. Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
6. Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study.
7. Willing and able to comply with study visits and study related requirements including providing written informed consent.

Exclusion Criteria (Subjects who meet any of the following criteria are not eligible for participation in the study):

1. Prior treatment with serlopitant.
2. Active pruritic skin disease, other than PN, within 6 months (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks).

3. Treatment with any of the following therapies within 4 weeks.

   1. Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant).
   2. Systemic or topical immunosuppressive/immunomodulatory therapies.
   3. Systemic therapies with recognized anti-pruritic properties.
   4. Strong cytochrome-P 3A4 inhibitors.
   5. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.
4. Treatment with topical anti-pruritic therapies within 2 weeks.
5. Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer.
6. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer.
7. Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.
8. Untreated or inadequately treated thyroid adrenal, or pituitary nodules or disease, or history of thyroid malignancy.
9. Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
10. Relevant major psychiatric diagnosis in the past 3 years, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
11. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks.
12. Any medical condition or disability that could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject.
13. History of hypersensitivity to serlopitant or any of its components.
14. Currently pregnant or breastfeeding or planning to become pregnant during the study.
15. Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments during participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.	At Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10	The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.	At Weeks 2, 4, and 10
Percent of Subjects With WI-NRS 4-point Responder at Week 4	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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 Week 4
Percent of Subjects With WI-NRS 4-point Responder at Week 2	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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 Week 2
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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, and 10
Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week.	At Weeks 2, 4, and 10
Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10	The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.	At Weeks 2, 4, and 10
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10	Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.	At Week 10
Change From Baseline in DLQI Question 1 to Week 10	DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.	At Week 10
Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)	Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.	35 days (+3 days) after Week 10 or Early Treatment Discontinuation

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

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

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Dermatitis; Skin Diseases, Eczematous; Pruritus; Prurigo; Neurodermatitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurokinin-1 Receptor Antagonists; Serlopitant
• Other Study ID Numbers: MTI-105

Drug and device information, study documents

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