NCT03630939

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis

A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Escalier Biosciences B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).

Conditions

• Psoriatic Plaque

Interventions

Type	Name	Description
DRUG	ESR-114	ESR-114 Topical Gel
OTHER	Placebo	Placebo Topical Gel

Timeline

• Start date: 2018-08-09
• Primary completion: 2019-06-05
• Completion: 2019-06-12
• First posted: 2018-08-15
• Last updated: 2020-07-29

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study