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Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JTE-451 Administered for 4 Weeks in Subjects With Active Plaque Psoriasis

NCT03018509•Akros Pharma Inc.

View on ClinicalTrials.gov

Summary

Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy target lesion).
•Each of the two target lesions must have a psoriatic lesion severity sum (PLSS) of ≥6
•Body mass index (BMI) of 18 to 38 kg/m2 (inclusive)

Exclusion Criteria

•Prior exposure to \>2 systemic biologic agents and/or small molecules including investigational therapies for the treatment of psoriasis or have not discontinued systemic biologic agents and/or small molecules anti-psoriasis therapy including investigational therapies due to lack of efficacy;
•Subjects with significant health problems, other than having plaque psoriasis (as determined by medical history, physical examination, chest X-ray, vital signs and 12-lead ECG) that could either interfere with study evaluations or place subject at undue risk;
•Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis at Visit 1;
•Conditions (e.g., clinically-significant eczema or severe acne in the target lesion area) that would interfere with study evaluations;
•Positive quantiFERON®-TB Gold test, negative chest X-ray findings for tubercle bacillus (TB) or lack any other evidence of active or latent TB;
•History of a clinically-significant infection (e.g., required oral antimicrobial therapy) within 4 weeks prior to Visit 2;
•Subjects who do not have clinical laboratory test results within the normal reference ranges (i.e., are deemed not to be clinically significant) or clinically not acceptable to the Investigator;

Locations (5)

Surrey, British Columbia, Canada

Markham, Ontario, Canada

Peterborough, Ontario, Canada

Richmond Hill, Ontario, Canada

Waterloo, Ontario, Canada

Key Dates

Start Date

December 1, 2016

Primary Completion Date

June 20, 2017

Completion Date

June 20, 2017

Last Updated

July 2, 2017

Enrollment

ACTUAL participants

Conditions

Plaque PsoriasisPsoriasisSkin Diseases

Interventions

JTE-451

DRUG

Placebo

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: July 2, 2017Data 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 Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects

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