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This Phase 2 study (Study 203) has been designed to determine and compare the efficacy and safety of 188-0551 Solution and Vehicle Solution applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Solution or Vehicle Solution) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 188-0551 Solution | Experimental | 188-0551 Solution applied topically twice daily |
|
| Vehicle Solution | Placebo Comparator | Vehicle Solution applied topically twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 188-0551 Solution | Drug | Topical solution containing active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) | The primary efficacy endpoint will be the proportion of subjects with IGA treatment success at EOS where EOS is the subject's last completed post-Baseline visit (Day 15 or 29). | End of Study (Day 15 or 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) | Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Arlington Heights | Illinois | 60005 | United States |
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| Vehicle Solution |
| Drug |
Topical solution containing no active drug |
|
| End of Study (Day 15 or 29) |
| Change from Baseline in pruritus score | At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. At Days 15 and 29, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire. | End of Study (Day 15 or 29) |