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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837743
• Other study ID #: C928-015
• Status: Completed
• Phase: Phase 2
• Start date: February 21, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: August 2022
• Source: Durect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 20, 2020
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DUR-928 Topical Solution
Topical solution containing active drug
• Vehicle Topical Solution
Topical solution containing no active drug

Locations

Country	Name	City	State
United States	Site 04	Miami	Florida
United States	Site 02	Plainfield	Indiana
United States	Site 01	San Diego	California
United States	Site 03	Spokane	Washington
United States	Site 05	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Durect	Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Change From Baseline as Assessed on the Target Plaque Comparison	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.	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)
Primary	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	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	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.	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	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.	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	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.	Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Secondary	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."	Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)