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

Escalier Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psoriatic Plaque

Treatments: Other: Placebo; Drug: ESR-114

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03630939

ESR-114-101

Details and patient eligibility

About

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).

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 3 patient groups, including a placebo group

ESR-114 1.5%

Experimental group

Description:

ESR-114 1.5% Topical Gel BID for 6 weeks

Treatment:

Drug: ESR-114

ESR-114 5.0%

Experimental group

Description:

ESR-114 5.0% Topical Gel BID for 6 weeks

Treatment:

Drug: ESR-114

Vehicle Gel

Placebo Comparator group

Description:

Placebo Topical Gel BID for 6 weeks

Treatment:

Other: Placebo