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

Psoriatic Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630939
• Other study ID #: ESR-114-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 9, 2018
• Est. completion date: June 12, 2019

Study information

• Verified date: July 2020
• Source: Escalier Biosciences B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 12, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriatic Plaque

Intervention

Drug:
• ESR-114
ESR-114 Topical Gel

Other:
• Placebo
Placebo Topical Gel

Locations

Country	Name	City	State
Canada	Study Site 10	Montréal	Quebec
Canada	Study Site 13	Peterborough	Ontario
United States	Study Site 12	Austin	Texas
United States	Study Site 11	College Station	Texas
United States	Study Site 17	Fridley	Minnesota
United States	Study Site 15	Houston	Texas
United States	Study Site 14	Raleigh	North Carolina
United States	Study Site 18	San Antonio	Texas
United States	Study Site 19	Santa Monica	California
United States	Study Site 16	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Escalier Biosciences B.V.	Innovaderm Research Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of subjects with PASI75	Proportion of subjects with PASI75 at Week 6	6 weeks
Secondary	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
Secondary	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
Secondary	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