NCT03630939CompletedPhase 1
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
Escalier Biosciences B.V.10 sites in 2 countries104 target enrollmentStarted: August 9, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Escalier Biosciences B.V.
- Enrollment
- 104
- Locations
- 10
- Primary Endpoint
- Change in Total Lesion Severity Score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Subject has total LSS of ≥6 at Day
- •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
- •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
- •Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.
Arms & Interventions
ESR-114 1.5%
Experimental
ESR-114 1.5% Topical Gel BID for 6 weeks
Intervention: ESR-114 (Drug)
ESR-114 5.0%
Experimental
ESR-114 5.0% Topical Gel BID for 6 weeks
Intervention: ESR-114 (Drug)
Vehicle Gel
Placebo Comparator
Placebo Topical Gel BID for 6 weeks
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in Total Lesion Severity Score
Time Frame: 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 Outcomes
- Change from Baseline in erythema score over time(6 weeks)
- Change from Baseline in induration score over time(6 weeks)
- Proportion of subjects with PASI75(6 weeks)
- Proportion of subjects with clear or almost clear on the Physician Global Assessment(6 weeks)
- Change from Baseline in desquamation score over time(6 weeks)
Investigators
Study Sites (10)
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