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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Psoriatic Plaque

In brief

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).

Key facts

Study ID

NCT03630939

Run by

Escalier Biosciences B.V.

People needed

104

Starts

2018-08-09

Expected to finish

2019-06-12

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study Site 19 — Santa Monica, California, United States
• Study Site 16 — Tampa, Florida, United States
• Study Site 17 — Fridley, Minnesota, United States
• Study Site 14 — Raleigh, North Carolina, United States
• Study Site 12 — Austin, Texas, United States
• Study Site 11 — College Station, Texas, United States
• Study Site 15 — Houston, Texas, United States
• Study Site 18 — San Antonio, Texas, United States
• Study Site 13 — Peterborough, Ontario, Canada
• Study Site 10 — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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