Plaque Psoriasis, Psoriasis, Skin Diseases
Conditions
Keywords
JTE-451, psoriasis
Brief summary
Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
Interventions
DRUGJTE-451
Active drug tablets containing JTE-451
DRUGPlacebo
Placebo tablets identical in appearance to the active drug tablets
Sponsors
Akros Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | 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 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 |
Countries
Canada
Outcome results
None listed