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

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

Official Title
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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

Conditions
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Plaque Psoriasis, Psoriasis, Skin Diseases

Intervention / Treatment
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* Drug: JTE-451
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JTE-451 Dose 1<br>JTE-451 dose 1 for 28 days | Drug: JTE-451<br>* Active drug tablets containing JTE-451<br>|
| Experimental: JTE-451 Dose 2<br>JTE-451 dose 2 for 28 days | Drug: JTE-451<br>* Active drug tablets containing JTE-451<br>|
| Experimental: JTE-451 Dose 3<br>JTE-451 dose 3 for 28 days | Drug: JTE-451<br>* Active drug tablets containing JTE-451<br>|
| Experimental: JTE-451 Dose 4<br>JTE-451 dose 4 for 28 days | Drug: JTE-451<br>* Active drug tablets containing JTE-451<br>|
| Experimental: Placebo<br>Placebo for 28 days | Drug: Placebo<br>* Placebo tablets identical in appearance to the active drug tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 4 weeks | 
| Percent change from baseline in the clinical target PLSS |  | Weeks 1, 2, 3 and 4 | 
| Percent change from baseline in the clinical target lesion erythema |  | Weeks 1, 2, 3 and 4 | 
| Percent change from baseline in the clinical target lesion induration |  | Weeks 1, 2, 3 and 4 | 
| Percent change from baseline in the clinical target lesion scaling |  | Weeks 1, 2, 3 and 4 | 
| Change from baseline in the clinical target lesion sPGA score |  | Weeks 1, 2, 3 and 4 | 
| Number of subjects with clinical target lesion sPGA scores of 0 or 1 |  | Week 1 | 
| Number of subjects with clinical target lesion sPGA scores of 0 or 1 |  | Week 2 | 
| Number of subjects with clinical target lesion sPGA scores of 0 or 1 |  | Week 3 | 
| Number of subjects with clinical target lesion sPGA scores of 0 or 1 |  | Week 4 | 
| Number of subjects with at least a 2-point improvement in sPGA score |  | Baseline to Week 4 | 
| Trough concentration during multiple dosing prior to next dose (Ctrough) |  | Weeks 1, 2, 3 and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JTE-451, psoriasis