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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000463-83 | EudraCT Number |
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This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Regimen 1 | Experimental | Subcutaneous injection |
|
| Active Comparator | Active Comparator | Subcutaneous injection |
|
| Placebo | Placebo Comparator | Subcutaneous injection |
|
| Dosing Regimen 2 | Experimental | Subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention A | Biological | Prefilled syringe. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PASI (psoriasis area and severity index) and IGA (investigator's global assessment) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI (psoriasis area and severity index) and IGA (investigator's global assessment) | Week 52 | |
| Vital signs, laboratory values, electrocardiograms (ECG), adverse events | Week 12 and 52 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| Intervention B |
| Biological |
Prefilled syringe. |
|
| Placebo | Biological | Prefilled syringe to match experimental drug and active comparator. |
|
| Patient reported outcome questionnaires |
| Week 12 and 52 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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