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

Phase 1

Completed

• Conditions: Psoriatic Plaque
• Interventions: Other: Placebo; Drug: ESR-114

• Registration Number: NCT03630939
• Lead Sponsor: Escalier Biosciences B.V.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-09
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Gel	Placebo	Placebo Topical Gel BID for 6 weeks
ESR-114 1.5%	ESR-114	ESR-114 1.5% Topical Gel BID for 6 weeks
ESR-114 5.0%	ESR-114	ESR-114 5.0% Topical Gel BID for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change in Total Lesion Severity Score	6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in erythema score over time	6 weeks	Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Change from Baseline in induration score over time	6 weeks	Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Proportion of subjects with PASI75	6 weeks	Proportion of subjects with PASI75 at Week 6
Proportion of subjects with clear or almost clear on the Physician Global Assessment	6 weeks	Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6
Change from Baseline in desquamation score over time	6 weeks	Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

Trial Locations

Locations (10)

Study Site 14; 🇺🇸 Raleigh, North Carolina, United States

Study Site 18; 🇺🇸 San Antonio, Texas, United States

Study Site 15; 🇺🇸 Houston, Texas, United States

Study Site 12; 🇺🇸 Austin, Texas, United States

Study Site 17; 🇺🇸 Fridley, Minnesota, United States

Study Site 19; 🇺🇸 Santa Monica, California, United States

Study Site 16; 🇺🇸 Tampa, Florida, United States

Study Site 11; 🇺🇸 College Station, Texas, United States

Study Site 13; 🇨🇦 Peterborough, Ontario, Canada

Study Site 10; 🇨🇦 Montréal, Quebec, Canada