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Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DUR-928 Topical Solution
Vehicle Topical Solution
Sponsored by
Durect
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 a male or non-pregnant female 18 years of age or older.
  2. Subject has provided written informed consent.
  3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months.
  4. 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 Visit 2/Baseline.
  5. Males (or their female partner) must agree to use an effective method of birth control throughout the study.
  6. Subject has two similar contralateral Target Plaques.
  7. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
  8. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis.
  4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient 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 test article.

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

Sites / Locations

  • Site 01
  • Site 04
  • Site 05
  • Site 02
  • Site 03

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DUR-928 Topical Solution

Vehicle Topical Solution

Arm Description

DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.

Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.

Outcomes

Primary Outcome Measures

The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe

Secondary Outcome Measures

The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.
The Change From Baseline as Assessed by the Target Plaque Area.
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."

Full Information

First Posted
February 5, 2019
Last Updated
August 12, 2022
Sponsor
Durect
Collaborators
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03837743
Brief Title
Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
May 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durect
Collaborators
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 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DUR-928 Topical Solution
Arm Type
Experimental
Arm Description
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Arm Title
Vehicle Topical Solution
Arm Type
Placebo Comparator
Arm Description
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Intervention Type
Drug
Intervention Name(s)
DUR-928 Topical Solution
Intervention Description
Topical solution containing active drug
Intervention Type
Drug
Intervention Name(s)
Vehicle Topical Solution
Intervention Description
Topical solution containing no active drug
Primary Outcome Measure Information:
Title
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
Description
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
Time Frame
Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Secondary Outcome Measure Information:
Title
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Description
Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.
Time Frame
Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Title
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
Description
The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.
Time Frame
Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Title
The Change From Baseline as Assessed by the Target Plaque Area.
Description
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
Time Frame
Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Title
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
Description
The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
Time Frame
Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Other Pre-specified Outcome Measures:
Title
The Change From Baseline as Assessed on the Target Plaque Comparison
Description
The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.
Time Frame
Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is a male or non-pregnant female 18 years of age or older. Subject has provided written informed consent. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months. 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 Visit 2/Baseline. Males (or their female partner) must agree to use an effective method of birth control throughout the study. Subject has two similar contralateral Target Plaques. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient 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 test article. Other protocol-defined inclusion and 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 01
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site 04
City
Miami
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Site 05
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Site 02
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Site 03
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis

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