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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JTE-451 Dose 1 | Experimental | JTE-451 dose 1 for 28 days |
|
| JTE-451 Dose 2 | Experimental | JTE-451 dose 2 for 28 days |
|
| JTE-451 Dose 3 | Experimental | JTE-451 dose 3 for 28 days |
|
| JTE-451 Dose 4 | Experimental | JTE-451 dose 4 for 28 days |
|
| Placebo | Experimental | Placebo for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTE-451 | Drug | Active drug tablets containing JTE-451 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey | British Columbia | Canada | ||||
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Drug | Placebo tablets identical in appearance to the active drug tablets |
|
| Baseline to Week 4 |
| Trough concentration during multiple dosing prior to next dose (Ctrough) | Weeks 1, 2, 3 and 4 |
| Markham |
| Ontario |
| Canada |
| Peterborough | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| Waterloo | Ontario | Canada |