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

NCT03841331 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MTI-117
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 41

Brief Summary

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

Conditions

Pruritus

Keywords

Pruritus

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  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

  At Week 10

Study Arms (2)

5 mg Serlopitant Tablets

EXPERIMENTAL

Serlopitant Tablets

Drug: 5 mg Serlopitant Tablets

5 mg Placebo Tablets

PLACEBO COMPARATOR

Placebo Tablets

Drug: Matching Placebo Tablets

Interventions

5 mg Serlopitant Tablets DRUG

Serlopitant Tablets

Also known as: VPD-737

5 mg Serlopitant Tablets

Matching Placebo Tablets DRUG

Placebo Tablets

5 mg Placebo Tablets

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (41)

Study Site 221

Hot Springs, Arkansas, 72022, United States

Location

Study Site 823

Bakersfield, California, 93301, United States

Location

Study Site 204

Fremont, California, 94538, United States

Location

Study Site 803

Los Angeles, California, 90045, United States

Location

Study Site 820

Centennial, Colorado, 80112, United States

Location

Study Site 804

Denver, Colorado, 80210, United States

Location

Study Site 811

Aventura, Florida, 33180, United States

Location

Study Site 801

Jacksonville, Florida, 32256, United States

Location

Study Site 807

Miami, Florida, 33137, United States

Location

Study Site 331

Miami, Florida, 33144, United States

Location

Study Site 824

Sarasota, Florida, 34239, United States

Location

Study Site 818

West Palm Beach, Florida, 33406, United States

Location

Study Site 349

Savannah, Georgia, 31406, United States

Location

Study Site 814

Indianapolis, Indiana, 46250, United States

Location

Study Site 808

Brighton, Massachusetts, 02135, United States

Location

Study Site 822

Rolla, Missouri, 65401, United States

Location

Study Site 371

Saint Joseph, Missouri, 64506, United States

Location

Study Site 817

St Louis, Missouri, 63110, United States

Location

Study Site 821

Bellevue, Nebraska, 68123, United States

Location

Study Site 813

Las Vegas, Nevada, 89128, United States

Location

Study Site 387

Las Vegas, Nevada, 89148, United States

Location

Study Site 816

Morristown, New Jersey, 07960, United States

Location

Study Site 121

Ocean Township, New Jersey, 07712, United States

Location

Study Site 507

Brooklyn, New York, 11203, United States

Location

Study Site 802

The Bronx, New York, 10458, United States

Location

Study Site 341

High Point, North Carolina, 27262, United States

Location

Study Site 810

Raleigh, North Carolina, 27612, United States

Location

Study Site 524

Dublin, Ohio, 43016, United States

Location

Study Site 116

Portland, Oregon, 97202, United States

Location

Study Site 522

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Site 345

Johnston, Rhode Island, 02919, United States

Location

Study Site 815

Warwick, Rhode Island, 02886, United States

Location

Study Site 805

Nashville, Tennessee, 37215, United States

Location

Study Site 365

Austin, Texas, 78745, United States

Location

Study Site 120

Dallas, Texas, 75231, United States

Location

Study Site 819

Fort Worth, Texas, 76244, United States

Location

Study Site 359

Pflugerville, Texas, 78660, United States

Location

Study Site 809

San Antonio, Texas, 78229, United States

Location

Study Site 217

Norfolk, Virginia, 23502, United States

Location

Study Site 806

Spokane, Washington, 99202, United States

Location

Study Site 812

Walla Walla, Washington, 09362, United States

Location

MeSH Terms

Conditions

Pruritus

Interventions

serlopitant

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Iain Stuart
• Organization: Menlo Therapeutics, Inc.

Iain.Stuart@foamix.com

1-800-775-7936

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: January 22, 2019
• Primary Completion: December 10, 2019
• Study Completion: January 21, 2020
• Last Updated: May 20, 2021
• Results First Posted: September 23, 2020

Record last verified: 2021-05

Locations

US (41)