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Completed

NCT Number: NCT03837743

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 01, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DUR-928 Topical Solution

Drug

Topical solution containing active drug

Vehicle Topical Solution

Drug

Topical solution containing no active drug

Primary outcomes

  1. The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.

    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)

    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 outcomes

  1. The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)

    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)

    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.

  2. The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)

    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)

    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.

  3. The Change From Baseline as Assessed by the Target Plaque Area.

    Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)

    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 Itch Numeric Rating Scale (I-NRS) for Pruritus.

    Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)

    The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."

Other outcomes

  1. The Change From Baseline as Assessed on the Target Plaque Comparison

    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)

    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.

Sponsors and collaborators

Lead sponsor

Durect

Industry

Collaborators

  • Therapeutics, Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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