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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-09

Study Completion Date

2019-06-12

Brief Summary

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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).

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Detailed Description

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Conditions

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Psoriatic Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ESR-114 1.5%

ESR-114 1.5% Topical Gel BID for 6 weeks

Group Type EXPERIMENTAL

ESR-114

Intervention Type DRUG

ESR-114 Topical Gel

ESR-114 5.0%

ESR-114 5.0% Topical Gel BID for 6 weeks

Group Type EXPERIMENTAL

ESR-114

Intervention Type DRUG

ESR-114 Topical Gel

Vehicle Gel

Placebo Topical Gel BID for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Topical Gel

Interventions

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ESR-114

ESR-114 Topical Gel

Intervention Type DRUG

Placebo

Placebo Topical Gel

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No