Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

• Status: Completed
• Trial end date: 2020-01-09
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermavant Sciences GmbH

Criteria

Inclusion Criteria:

• Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study

• BSA involvement ≥ 20%

• PGA score of ≥ 3 at screening

• Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study

• Capable of giving written informed consent

Exclusion Criteria:

• Psoriasis other than plaque variant

• Any sign of infection of any of the psoriatic lesions

• Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results

• Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis

• Use of any prohibited medication within the indicated period before the first dose of study drug

• Pregnant females or lactating females

• The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug

• Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix

• Previous known participation in a clinical study with tapinarof