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

Durect

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Vehicle Topical Solution; Drug: DUR-928 Topical Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03837743

C928-015

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

DUR-928 Topical Solution

Experimental group

Description:

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

Treatment:

Drug: DUR-928 Topical Solution

Vehicle Topical Solution

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle Topical Solution