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The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK4827 | Experimental | KHK4827 administered SC |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK4827 | Drug | Administered KHK4827 by subcutaneous (SC) injection until week 62. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis area and severity index (PASI) 75 response | at week 12 | |
| Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)" | at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 50/75/90/100 response by visit | Baseline to week 64 | |
| sPGA of "0 (clear) or 1 (almost clear)" by visit | Baseline to week 64 | |
| Body surface area (BSA) involvement of lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea, Republic of | Seoul | 49241 | South Korea |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Placebo | Drug | Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62. |
|
| Baseline to week 64 |
| Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline) | Baseline to week 64 |
| Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline) | Baseline to week 64 |
| Dermatology life quality index (DLQI) | Baseline to week 64 |
| Treatment-emergent adverse events (TEAEs) or drug-related TEAEs | Baseline to week 64 |
| Laboratory values | Baseline to week 64 |
| Vital signs | Baseline to week 64 |
| Anti-KHK4827 antibodies | Baseline, Week 12, Week 24, Week 48, Week 64 |
| Serum KHK4827 concentration | Baseline, Week 8, Week 10, Week 12, Week 24 |