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

Status:	Recruiting
Conditions:	Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - Any
Updated:	12/29/2018
Start Date:	August 9, 2018
End Date:	June 11, 2019
Contact:	MiRa Huyghe
Email:	mhuyghe@escalierbio.com
Phone:	1 760 456 2012

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

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).

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.

We found this trial at

sites

Study Site 14

Raleigh, North Carolina 27612

from

Raleigh, NC