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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837743
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Durect
Information provided by (Responsible Party):
Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DUR-928 Topical Solution Drug: Vehicle Topical Solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 21, 2019
Actual Primary Completion Date : November 11, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DUR-928 Topical Solution
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: DUR-928 Topical Solution
Topical solution containing active drug

Placebo Comparator: Vehicle Topical Solution
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: Vehicle Topical Solution
Topical solution containing no active drug




Primary Outcome Measures :
  1. The change from Baseline as assessed on the Investigator's Global Assessment (IGA) Score. [ Time Frame: Up to Day 57 ]
    The IGA of the Target Plaques will be determined on a 5-point scale ranging from "Clear - 0" to "Severe - 4."


Secondary Outcome Measures :
  1. The change from Baseline as assessed on the Clinical Signs of Psoriasis (plaque elevation, scaling, and erythema) [ Time Frame: Up to Day 57 ]
    Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale ranging from "Clear - 0" to "Severe - 4."

  2. The change from Baseline as assessed on the Local Psoriasis Severity Index (LPSI) [ Time Frame: Up to Day 57 ]
    The LPSI is a sum of all three parameters including plaque elevation, scaling, and erythema.

  3. The change from Baseline as assessed by the Target Plaque Area. [ Time Frame: Up to Day 57 ]
    The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.

  4. The change from Baseline as assessed on the Numeric Rating Scale (NRS) for Pruritus. [ Time Frame: Up to Day 57 ]
    The NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."


Other Outcome Measures:
  1. The change from Baseline as assessed on the Target Plaque Comparison [ Time Frame: Up to Day 57 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837743


Locations
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United States, California
Site 01
San Diego, California, United States, 92123
United States, Florida
Site 05
Brandon, Florida, United States, 33511
Site 04
Miami, Florida, United States, 33162
United States, Indiana
Site 02
Plainfield, Indiana, United States, 46168
United States, Washington
Site 03
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Therapeutics, Inc.
Durect
Investigators
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Study Director: Tony Andrasfay Therapeutics, Inc.

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Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03837743    
Other Study ID Numbers: C928-015
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Pharmaceutical Solutions