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

Escalier Biosciences B.V.104 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

104

Conditions

Psoriatic Plaque

Interventions

ESR-114DRUG

ESR-114 Topical Gel

PlaceboOTHER

Placebo Topical Gel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has a history of plaque psoriasis for at least 6 months. * Subject has PGA of mild (2) or moderate (3) at Day 1. * Subject has total LSS of ≥6 at Day 1. * Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1. Exclusion Criteria: * Subject has non-plaque psoriasis at Screening and Day 1. * Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1. * Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.

Locations (10)

Study Site 19

Santa Monica, California, United States

Study Site 16

Tampa, Florida, United States

Study Site 17

Fridley, Minnesota, United States

Study Site 14

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

Change in Total Lesion Severity Score

Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, \& Desquamation; score range: 0-12; lower score is better outcome) at Week 6

Time frame: 6 weeks

Secondary Outcomes

Proportion of subjects with clear or almost clear on the Physician Global Assessment

Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6

Time frame: 6 weeks

Proportion of subjects with PASI75

Proportion of subjects with PASI75 at Week 6

Time frame: 6 weeks

Change from Baseline in erythema score over time

Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

Time frame: 6 weeks

Change from Baseline in induration score over time

Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

Time frame: 6 weeks

Change from Baseline in desquamation score over time

Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

Time frame: 6 weeks

Data from ClinicalTrials.gov

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