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Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
188-0551 Spray
Vehicle Spray
Sponsored by
Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent.
  2. Subject has provided written informed consent.
  3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas).
  4. Subject has moderate to severe plaque psoriasis.
  5. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

  1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
  3. Subject has palmar/plantar psoriasis.
  4. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  5. Subject is currently enrolled in an investigational drug or device study.
  6. Subject has been previously enrolled in this study and treated with a test article.

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Sites / Locations

  • Site 04
  • Site 14
  • Site 01
  • Site 11
  • Site 13
  • Site 10
  • Site 12
  • Site 07
  • Site 06
  • Site 05
  • Site 03
  • Site 15
  • Site 08
  • Site 02

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: 188-0551 Spray

Vehicle Spray

Arm Description

188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks

Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks

Outcomes

Primary Outcome Measures

Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) Success
The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).

Secondary Outcome Measures

Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Change from Baseline in pruritus score
The proportion of subjects with ≥4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
IGA "treatment success" at Day 15
The proportion of subjects with IGA "treatment success" at Day 15.

Full Information

First Posted
November 2, 2018
Last Updated
February 18, 2020
Sponsor
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03731052
Brief Title
Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)
Official Title
A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Efficacy and Safety of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis Receiving Up to Four Weeks of Twice-Daily Treatment (Study 307)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 3 study (Study 307) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: 188-0551 Spray
Arm Type
Experimental
Arm Description
188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
Arm Title
Vehicle Spray
Arm Type
Placebo Comparator
Arm Description
Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
Intervention Type
Drug
Intervention Name(s)
188-0551 Spray
Intervention Description
Topical Spray containing active drug
Intervention Type
Drug
Intervention Name(s)
Vehicle Spray
Intervention Description
Topical Spray containing no active drug
Primary Outcome Measure Information:
Title
Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) Success
Description
The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
Description
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Time Frame
Day 29
Title
Change from Baseline in pruritus score
Description
The proportion of subjects with ≥4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
Time Frame
Day 29
Title
IGA "treatment success" at Day 15
Description
The proportion of subjects with IGA "treatment success" at Day 15.
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent. Subject has provided written informed consent. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas). Subject has moderate to severe plaque psoriasis. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit. Exclusion Criteria: Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis. Subject has palmar/plantar psoriasis. Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject is currently enrolled in an investigational drug or device study. Subject has been previously enrolled in this study and treated with a test article. Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Andrasfay
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 04
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Site 14
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Site 01
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Site 11
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Site 13
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Site 10
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Site 12
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Site 07
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site 06
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Site 05
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Site 03
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Site 15
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Site 08
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 02
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

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