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Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC10004 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC10004 | Drug | 2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis. | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases. | 58 days | |
| To explore the clinical efficacy of orally administered CC10004 when taken for 29 days in subjects with severe plaque-type psoriasis. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Dentistry of New Jersey | New Brunswick | New Jersey | 08903 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18419879 | Background | Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008 May;24(5):1529-38. doi: 10.1185/030079908x301866. Epub 2008 Apr 16. |
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| 29 days |
| To explore the clinical efficacy of CC10004 when taken for 29 days in subjects with psoriatic arthritis. | 29 days |
| NYU School of Medicine |
| New York |
| New York |
| 10016 |
| United States |
| Mt Sinai School of Medicine | New York | New York | 10029 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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