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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: DUR-928 Topical Solution; Drug: Vehicle Topical Solution

• Registration Number: NCT03837743
• Lead Sponsor: Durect

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-02-21
• Primary Completion: 2019-11-11
• Study Completion: 2020-05-20
• Disposition First Submitted: 2020-05-28
• Results First Submitted: 2022-05-27
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-12
• Disposition First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Results First Posted: 2022-09-02
• Disposition First Posted: 2022-09-02
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.	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 Outcome Measures

Name	Time	Method
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 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 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)	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 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 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.	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."

Trial Locations

Locations (5)

Site 05; 🇺🇸 Tampa, Florida, United States

Site 02; 🇺🇸 Plainfield, Indiana, United States

Site 03; 🇺🇸 Spokane, Washington, United States

Site 01; 🇺🇸 San Diego, California, United States

Site 04; 🇺🇸 Miami, Florida, United States