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VPD-737 for Treatment of Chronic Pruritus

Primary Purpose

Chronic Pruritus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VPD-737
Placebo
Sponsored by
Vyne Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pruritus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria:

  • Have chronic liver or renal disease

Sites / Locations

  • Center for Dermatology Clinical Research, Inc.
  • Torrance Clinical Research Institute Inc.
  • Stanford University, Medical Dermatology
  • UCSD Dermatology
  • The Center for Clinical and Cosmetic Research
  • Dermatology of Boca
  • Skin Care Research
  • Olympian Clinical Research
  • Advanced Medical Research, Inc.
  • Shideler Clinical Research Center
  • The Indiana Clinical Trials Center, PC
  • Grekin Skin Institue
  • Minnesota Clinical Study Center
  • Quality Clinical Research Inc.
  • Comprehensive Clinical Research
  • The Dermatology Group, P.C.
  • Skin Search of Rochester, Inc.
  • Dermatology Consulting Services
  • Baker Allergy, Asthma and Dermatology Research Center, LLC
  • Temple University
  • Suzanne Bruce and Associates, P.A.
  • Pfugerville Dermatology
  • Dermatology Clinical Research Center of San Antonio
  • WestEnd Dermatology Associates
  • Marycliff Allergy Specialist

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

0.25 mg VPD-737

1 mg VPD-737

5 mg VPD-737

Placebo

Arm Description

0.25 mg of VPD-737 daily by mouth for 42 days

1 mg VPD-737 taken daily by mouth for 42 days

5 mg tablets of VPD-737 to be taken daily by mouth for 42 days

placebo tablets to be taken daily by mouth for 42 days

Outcomes

Primary Outcome Measures

Visual Analog Scale

Secondary Outcome Measures

Verbal Response Scale

Full Information

First Posted
July 19, 2013
Last Updated
May 10, 2022
Sponsor
Vyne Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01951274
Brief Title
VPD-737 for Treatment of Chronic Pruritus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2013 (Actual)
Primary Completion Date
December 2, 2014 (Actual)
Study Completion Date
December 2, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.25 mg VPD-737
Arm Type
Experimental
Arm Description
0.25 mg of VPD-737 daily by mouth for 42 days
Arm Title
1 mg VPD-737
Arm Type
Experimental
Arm Description
1 mg VPD-737 taken daily by mouth for 42 days
Arm Title
5 mg VPD-737
Arm Type
Experimental
Arm Description
5 mg tablets of VPD-737 to be taken daily by mouth for 42 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablets to be taken daily by mouth for 42 days
Intervention Type
Drug
Intervention Name(s)
VPD-737
Other Intervention Name(s)
Serlopitant
Intervention Description
NK1 Receptor Antagonist
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Visual Analog Scale
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Verbal Response Scale
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of chronic pruritus and unresponsive to current therapies Exclusion Criteria: Have chronic liver or renal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward F Schnipper, MD
Organizational Affiliation
Acting Chief Medical Officer, Tigercat Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Stanford University, Medical Dermatology
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
UCSD Dermatology
City
San Diego
State/Province
California
Country
United States
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Dermatology of Boca
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Skin Care Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Advanced Medical Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Grekin Skin Institue
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Quality Clinical Research Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
The Dermatology Group, P.C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Baker Allergy, Asthma and Dermatology Research Center, LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Suzanne Bruce and Associates, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Pfugerville Dermatology
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
WestEnd Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Marycliff Allergy Specialist
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29462657
Citation
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.
Results Reference
derived

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VPD-737 for Treatment of Chronic Pruritus

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