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Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-451 Administered for 16 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (IMPACT-PS)

NCT03832738•Akros Pharma Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (33)

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

Key Dates

Start Date

January 17, 2019

Primary Completion Date

March 13, 2020

Completion Date

March 13, 2020

Last Updated

August 20, 2021

Enrollment

152

ACTUAL participants

Conditions

Plaque PsoriasisPsoriasisSkin Diseases

Interventions

JTE-451 Tablets

DRUG

Placebo Tablets

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments