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

NCT03837743 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C928-015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

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

  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 Change From Baseline as Assessed by the Target Plaque Area.

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

• The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.

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

Other Outcomes (1)

• The Change From Baseline as Assessed on the Target Plaque Comparison

  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)

Study Arms (2)

DUR-928 Topical Solution

EXPERIMENTAL

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

Drug: DUR-928 Topical Solution

Vehicle Topical Solution

PLACEBO COMPARATOR

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

Drug: Vehicle Topical Solution

Interventions

DUR-928 Topical Solution DRUG

Topical solution containing active drug

DUR-928 Topical Solution

Vehicle Topical Solution DRUG

Topical solution containing no active drug

Vehicle Topical Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Durect: lead
• Therapeutics, Inc.: collaborator

Study Sites (5)

Site 01

San Diego, California, 92123, United States

Location

Site 04

Miami, Florida, 33162, United States

Location

Site 05

Tampa, Florida, 33609, United States

Location

Site 02

Plainfield, Indiana, 46168, United States

Location

Site 03

Spokane, Washington, 99202, United States

Location

Results Point of Contact

• Title: Executive Director of Regulatory Affairs
• Organization: DURECT Corporation

jill.burns@durect.com

408-777-1829

Study Officials

• Tony Andrasfay

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 12, 2019
• Study Start: February 21, 2019
• Primary Completion: November 11, 2019
• Study Completion: May 20, 2020
• Last Updated: September 2, 2022
• Results First Posted: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)