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

E

Escalier Biosciences

Status and phase

Completed
Phase 2
Phase 1

Conditions

Psoriatic Plaque

Treatments

Other: Placebo
Drug: ESR-114

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03630939
ESR-114-101

Details and patient eligibility

About

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).

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

104 participants in 3 patient groups, including a placebo group

ESR-114 1.5%
Experimental group
Description:
ESR-114 1.5% Topical Gel BID for 6 weeks
Treatment:
Drug: ESR-114
ESR-114 5.0%
Experimental group
Description:
ESR-114 5.0% Topical Gel BID for 6 weeks
Treatment:
Drug: ESR-114
Vehicle Gel
Placebo Comparator group
Description:
Placebo Topical Gel BID for 6 weeks
Treatment:
Other: Placebo

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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