drugset / Trial / NCT03837743

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

NCT03837743 ↗

Phase 2 Completed 25 enrolled Durect Therapeutics, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-02-21
Primary completion
2019-11-11
Completion
2020-05-20

Outcome

Missed primary endpoint

registry analysis (superiority test); DUR-928 Topical Solution vs Vehicle Topical Solution; p = 0.296; Mean Difference (Final Values) 0.2; Paired t-test NCT03837743 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Larsucosterol Small molecule — Topical

Indications