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| ID | Type | Description | Link |
|---|---|---|---|
| U0279-401 |
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Business decision. No patients were enrolled
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to assess the safety and efficacy of an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.
The study is being conducted in order to obtain safety and efficacy data for an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis. The subjects will be randomized to either U0279 or placebo after having been on an injectable biologic for 12 weeks previously. The subject will be on study medication for 12 weeks. The subjects must have moderate to severe Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | U0279 and Injectable Biologic |
|
| 2 | Placebo Comparator | Placebo and Injectable Biologic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acitretin (also called U0279) | Drug | Capsules containing 25 mg U0279 taken once a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoints - Mean change in % BSA psoriasis involvement from baseline to week 12 and the mean change in PASI score from baseline to Week 12. | Baseline & Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in PGA at week 12, % of subjects with improvement in PASI 50 to 75 from baseline to week 12 and % of subjects with improvement in PASI 75 to 90 from baseline to week 12. | Baseline & Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF - Dermatology Psoriasis & Skin Treatment Center | San Francisco | California | 94118 | United States | ||
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| 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 |
|---|---|
| D017255 | Acitretin |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Placebo |
| Drug |
Placebo capsules |
|
| Etanercept | Biological | Injectable Biologic |
|
|
| Physicians Skin Care |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Mt. Sinai School of Medicine Department of Dermatology | New York | New York | 10029 | United States |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |