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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03630939
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Escalier Biosciences B.V.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Allison Luo, MD
Principal Investigator Affiliation Escalier Biosciences B.V.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Plaque

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Study Site 19, Santa Monica, California

Status

Recruiting

Address

Study Site 19

Santa Monica, California, 90404

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 16, Tampa, Florida

Status

Recruiting

Address

Study Site 16

Tampa, Florida, 33624

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 17, Fridley, Minnesota

Status

Recruiting

Address

Study Site 17

Fridley, Minnesota, 55432

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 14, Raleigh, North Carolina

Status

Recruiting

Address

Study Site 14

Raleigh, North Carolina, 27612

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 12, Austin, Texas

Status

Recruiting

Address

Study Site 12

Austin, Texas, 78759

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 11, College Station, Texas

Status

Recruiting

Address

Study Site 11

College Station, Texas, 77845

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 15, Houston, Texas

Status

Recruiting

Address

Study Site 15

Houston, Texas, 77056

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 18, San Antonio, Texas

Status

Recruiting

Address

Study Site 18

San Antonio, Texas, 78213

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

International Sites

Study Site 13, Peterborough, Ontario, Canada

Status

Recruiting

Address

Study Site 13

Peterborough, Ontario, K9J 5K2

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

Study Site 10, Montréal, Quebec, Canada

Status

Recruiting

Address

Study Site 10

Montréal, Quebec, H2K 4L5

Site Contact

MiRa Huyghe

mhuyghe@escalierbio.com

1 760 456 2012

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