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

Study Purpose

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

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 - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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

    Exclusion Criteria:

    - 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.

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.

NCT03832738
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 2
Lead Sponsor

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

Akros Pharma Inc.
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

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

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

Plaque Psoriasis, Psoriasis, Skin Diseases
Arms & Interventions

Arms

Experimental: JTE-451 Dose 1

JTE-451 Tablets Dose 1 daily for 16 weeks.

Experimental: JTE-451 Dose 2

JTE-451 Tablets Dose 2 daily for 16 weeks.

Placebo Comparator: Placebo

Placebo Tablets daily for 16 weeks.

Interventions

Drug: - JTE-451 Tablets

Active drug tablets containing JTE-451

Drug: - Placebo Tablets

Placebo tablets matching in appearance to the active drug tablets

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.

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

Temecula, California

Status

Recruiting

Address

Advanced Dermatology and Skin Cancer Specialists

Temecula, California, 92592

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Central Sooner Research, Norman, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Health Concepts, Rapid City, South Dakota

Status

Recruiting

Address

Health Concepts

Rapid City, South Dakota, 57702

International Sites

Wiseman Dermatology Research Inc., Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4

Barrie, Ontario, Canada

Status

Recruiting

Address

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1

SKiN Health, Cobourg, Ontario, Canada

Status

Recruiting

Address

SKiN Health

Cobourg, Ontario, K9A 0B3

Research Toronto, Toronto, Ontario, Canada

Status

Recruiting

Address

Research Toronto

Toronto, Ontario, M4W 2N2

K. Papp Clinical Research, Waterloo, Ontario, Canada

Status

Recruiting

Address

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4

Diex Research Sherbrooke Inc., Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki nr 1 im. Dr. A. Jurasza w Bydgoszczy, Klinika Dermatologii, Chorob Prenoszonych Droga Plciowa

Bydgoszcz, , 85-094

Gdansk, Poland

Status

Recruiting

Address

Copernicus Podmiot Leczniczy Sp. z o.o., Oddzial Dermatologii

Gdansk, , 80-152

Kielce, Poland

Status

Recruiting

Address

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, , 25-316

Krakow, Poland

Status

Recruiting

Address

Centrum Nowoczesnych Terapii "Dobry Lekarz" Spolka z orgraniczona odpowiedzialnoscia

Krakow, , 31-011

Lodz, Poland

Status

Recruiting

Address

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akeyjna

Lodz, , 90-242

ETG Lodz, Lodz, Poland

Status

Recruiting

Address

ETG Lodz

Lodz, , 90-302

Lodz, Poland

Status

Recruiting

Address

Dermoklinika - Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak

Lodz, , 90-436

ETG Lublin, Lublin, Poland

Status

Recruiting

Address

ETG Lublin

Lublin, , 20-412

Centrum Medyczne Grunwald, Poznan, Poland

Status

Recruiting

Address

Centrum Medyczne Grunwald

Poznan, , 60-369

Solumed Centrum Medyczne, Poznan, Poland

Status

Recruiting

Address

Solumed Centrum Medyczne

Poznan, , 60-529

Rzeszow, Poland

Status

Recruiting

Address

Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii

Rzeszow, , 35-055

ETG Siedlce, Siedlce, Poland

Status

Recruiting

Address

ETG Siedlce

Siedlce, , 08-110

ETG Skierniewice, Skierniewice, Poland

Status

Recruiting

Address

ETG Skierniewice

Skierniewice, , 96-100

Clinical Research Group Sp. z o.o., Warszawa, Poland

Status

Recruiting

Address

Clinical Research Group Sp. z o.o.

Warszawa, , 01-142

Warszawa, Poland

Status

Recruiting

Address

Dorota Bystrzanowska "High-Med" Przychodnia Specjalistyczna

Warszawa, , 01-817

Carpe Diem Centrum Medycyny Estetycznej, Warszawa, Poland

Status

Recruiting

Address

Carpe Diem Centrum Medycyny Estetycznej

Warszawa, , 02-661

Royalderm Agnieszka Nawrocka, Warszawa, Poland

Status

Recruiting

Address

Royalderm Agnieszka Nawrocka

Warszawa, , 02-692

ETG Warszawa, Warszawa, Poland

Status

Recruiting

Address

ETG Warszawa

Warszawa, , 02-777

Wroclaw, Poland

Status

Recruiting

Address

CITYCLINIC Przychodnia Psychologiczno-Lekarska Matusiak Spolka Partnerska

Wroclaw, , 50-566

DERMMEDICA Sp. z o.o., Wrocław, Poland

Status

Recruiting

Address

DERMMEDICA Sp. z o.o.

Wrocław, , 51-318

ETG Zamosc, Zamosc, Poland

Status

Recruiting

Address

ETG Zamosc

Zamosc, , 22-400

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