VPD-737 for Treatment of Chronic Pruritus

A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus

A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments

Study Overview

• Status: Completed
• Conditions: Chronic Pruritus
• Intervention / Treatment: Drug: Placebo; Drug: VPD-737

Detailed Description

The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute Inc.
    • Redwood City, California, United States, 94063
      • Stanford University, Medical Dermatology
    • San Diego, California, United States
      • UCSD Dermatology
  • Florida
    • Aventura, Florida, United States, 33180
      • The Center for Clinical and Cosmetic Research
    • Boca Raton, Florida, United States, 33431
      • Dermatology of Boca
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Advanced Medical Research, Inc.
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institue
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research Inc.
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, P.C.
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Baker Allergy, Asthma and Dermatology Research Center, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, P.A.
    • Pflugerville, Texas, United States, 78660
      • Pfugerville Dermatology
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
  • Virginia
    • Richmond, Virginia, United States, 23233
      • WestEnd Dermatology Associates
  • Washington
    • Spokane, Washington, United States, 99204
      • Marycliff Allergy Specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria:

• Have chronic liver or renal disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.25 mg VPD-737; 0.25 mg of VPD-737 daily by mouth for 42 days	Drug: VPD-737; NK1 Receptor Antagonist; Other Names: Serlopitant
Experimental: 1 mg VPD-737; 1 mg VPD-737 taken daily by mouth for 42 days	Drug: VPD-737; NK1 Receptor Antagonist; Other Names: Serlopitant
Experimental: 5 mg VPD-737; 5 mg tablets of VPD-737 to be taken daily by mouth for 42 days	Drug: VPD-737; NK1 Receptor Antagonist; Other Names: Serlopitant
Placebo Comparator: Placebo; placebo tablets to be taken daily by mouth for 42 days	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Verbal Response Scale	6 weeks

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.
• Investigators: Study Director: Edward F Schnipper, MD, Acting Chief Medical Officer, Tigercat Pharma, Inc.

Publications and helpful links

General Publications

• Yosipovitch G, Stander S, Kerby MB, Larrick JW, Perlman AJ, Schnipper EF, Zhang X, Tang JY, Luger T, Steinhoff M. Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. J Am Acad Dermatol. 2018 May;78(5):882-891.e10. doi: 10.1016/j.jaad.2018.02.030. Epub 2018 Feb 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2013
• Primary Completion (Actual): December 2, 2014
• Study Completion (Actual): December 2, 2014

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• 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: TCP 101