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This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | po daily |
|
| RG3421 120mg | Experimental | 120mg po daily |
|
| RG3421 20mg | Experimental | 20mg po daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po daily |
| |
| RG3421 120mg |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), laboratory parameters, pharmacokinetics | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | 71913 | United States | |||
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| Drug |
120mg po daily |
|
| RG3421 20mg | Drug | 20mg po daily |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Santa Monica | California | 90404 | United States |
| Alpharetta | Georgia | 30005 | United States |
| East Windsor | New Jersey | 08520 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029 | United States |
| Stony Brook | New York | 11790 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Providence | Rhode Island | 02903 | United States |
| Nashville | Tennessee | 37215 | United States |
| Galveston | Texas | 77550 | United States |
| San Antonio | Texas | 78229 | United States |
| Webster | Texas | 77598 | 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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