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

Primary Purpose

Psoriatic Plaque

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ESR-114
Placebo
Sponsored by
Escalier Biosciences B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Plaque

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Study Site 19
  • Study Site 16
  • Study Site 17
  • Study Site 14
  • Study Site 12
  • Study Site 11
  • Study Site 15
  • Study Site 18
  • Study Site 13
  • Study Site 10

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ESR-114 1.5%

ESR-114 5.0%

Vehicle Gel

Arm Description

ESR-114 1.5% Topical Gel BID for 6 weeks

ESR-114 5.0% Topical Gel BID for 6 weeks

Placebo Topical Gel BID for 6 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Proportion of subjects with PASI75
Proportion of subjects with PASI75 at Week 6
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
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
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

Full Information

First Posted
August 10, 2018
Last Updated
July 27, 2020
Sponsor
Escalier Biosciences B.V.
Collaborators
Innovaderm Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03630939
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Escalier Biosciences B.V.
Collaborators
Innovaderm Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESR-114 1.5%
Arm Type
Experimental
Arm Description
ESR-114 1.5% Topical Gel BID for 6 weeks
Arm Title
ESR-114 5.0%
Arm Type
Experimental
Arm Description
ESR-114 5.0% Topical Gel BID for 6 weeks
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Placebo Topical Gel BID for 6 weeks
Intervention Type
Drug
Intervention Name(s)
ESR-114
Intervention Description
ESR-114 Topical Gel
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Topical Gel
Primary Outcome Measure Information:
Title
Change in Total Lesion Severity Score
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with clear or almost clear on the Physician Global Assessment
Description
Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6
Time Frame
6 weeks
Title
Proportion of subjects with PASI75
Description
Proportion of subjects with PASI75 at Week 6
Time Frame
6 weeks
Title
Change from Baseline in erythema score over time
Description
Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Time Frame
6 weeks
Title
Change from Baseline in induration score over time
Description
Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Time Frame
6 weeks
Title
Change from Baseline in desquamation score over time
Description
Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Luo, MD
Organizational Affiliation
Escalier Biosciences B.V.
Official's Role
Study Chair
Facility Information:
Facility Name
Study Site 19
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Study Site 16
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Study Site 17
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Study Site 14
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Study Site 12
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Study Site 11
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Study Site 15
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Study Site 18
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Study Site 13
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Study Site 10
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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