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

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 Overview

• Status: Completed
• Conditions: Psoriatic Plaque
• Intervention / Treatment: Drug: ESR-114; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Peterborough, Ontario, Canada, K9J 5K2
      • Study site 13
  • Quebec
    • Montréal, Quebec, Canada, H2K 4L5
      • Study site 10
• United States
  • California
    • Santa Monica, California, United States, 90404
      • Study site 19
  • Florida
    • Tampa, Florida, United States, 33624
      • Study site 16
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Study site 17
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Study site 14
  • Texas
    • Austin, Texas, United States, 78759
      • Study site 12
    • College Station, Texas, United States, 77845
      • Study site 11
    • Houston, Texas, United States, 77056
      • Study site 15
    • San Antonio, Texas, United States, 78213
      • Study site 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESR-114 1.5%; ESR-114 1.5% Topical Gel BID for 6 weeks	Drug: ESR-114; ESR-114 Topical Gel
Experimental: ESR-114 5.0%; ESR-114 5.0% Topical Gel BID for 6 weeks	Drug: ESR-114; ESR-114 Topical Gel
Placebo Comparator: Vehicle Gel; Placebo Topical Gel BID for 6 weeks	Other: Placebo; Placebo Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks
Proportion of subjects with PASI75	Proportion of subjects with PASI75 at Week 6	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	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	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	6 weeks

Collaborators and Investigators

• Sponsor: Escalier Biosciences B.V.
• Collaborators: Innovaderm Research Inc.
• Investigators: Study Chair: Allison Luo, MD, Escalier Biosciences B.V.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 12, 2019

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ESR-114-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No