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Completed

NCT Number: NCT03630939

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 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).

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Key information

Conditions

Psoriatic Plaque

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Study Site 13, Peterborough, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESR-114

Drug

ESR-114 Topical Gel

Placebo

Other

Placebo Topical Gel

Primary outcomes

  1. 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

  1. Proportion of subjects with clear or almost clear on the Physician Global Assessment

    Time frame: 6 weeks

    Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6

  2. Proportion of subjects with PASI75

    Time frame: 6 weeks

    Proportion of subjects with PASI75 at Week 6

  3. Change from Baseline in erythema score over time

    Time frame: 6 weeks

    Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

  4. Change from Baseline in induration score over time

    Time frame: 6 weeks

    Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

  5. Change from Baseline in desquamation score over time

    Time frame: 6 weeks

    Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

Sponsors and collaborators

Lead sponsor

Escalier Biosciences B.V.

Industry

Collaborators

  • Innovaderm Research Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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