Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis, Psoriasis, Skin Diseases

In brief

Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.

Key facts

Study ID

NCT03832738

Run by

Akros Pharma Inc.

People needed

152

Starts

2019-01-17

Expected to finish

2020-03-13

Last updated by the study team

2021-08-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have had a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1;
• Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2

You may not qualify if…

• History of discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator's judgment;
• Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;
• Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) at Visit 1;
• History or presence of itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin within 12 months prior to Visit 1.

Where it is running

• Clinical Science Institute — Santa Monica, California, United States
• Advanced Dermatology and Skin Cancer Specialists — Temecula, California, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Health Concepts — Rapid City, South Dakota, United States
• Wiseman Dermatology Research Inc. — Winnipeg, Manitoba, Canada
• SimcoDerm Medical and Surgical Dermatology Center — Barrie, Ontario, Canada
• SKiN Health — Cobourg, Ontario, Canada
• Research Toronto — Toronto, Ontario, Canada
• K. Papp Clinical Research — Waterloo, Ontario, Canada
• Diex Research Sherbrooke Inc. — Sherbrooke, Quebec, Canada
• Szpital Uniwersytecki nr 1 im. Dr. A. Jurasza w Bydgoszczy, Klinika Dermatologii, Chorob Prenoszonych Droga Plciowa — Bydgoszcz, Poland
• Copernicus Podmiot Leczniczy Sp. z o.o., Oddzial Dermatologii — Gdansk, Poland
• Prywatny Gabinet Dermatologiczny Elzbieta Klujszo — Kielce, Poland
• Centrum Nowoczesnych Terapii "Dobry Lekarz" Spolka z orgraniczona odpowiedzialnoscia — Krakow, Poland
• Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akeyjna — Lodz, Poland
• ETG Lodz — Lodz, Poland
• Dermoklinika - Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak — Lodz, Poland
• ETG Lublin — Lublin, Poland
• Centrum Medyczne Grunwald — Poznan, Poland
• Solumed Centrum Medyczne — Poznan, Poland
• Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii — Rzeszów, Poland
• ETG Siedlce — Siedlce, Poland
• ETG Skierniewice — Skierniewice, Poland

Full record on ClinicalTrials.gov

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