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This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK4827 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK4827 | Drug | 140 mg (dosage may be increased to 210 mg in case of insufficient efficacy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) | CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) | 52 weeks | |
| American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) | 52 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin | Chiyoda-ku | Tokyo | 100-8185 | Japan |
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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 |
|---|---|
| C571216 | brodalumab |
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| Pustular symptom score (only in subjects with pustular psoriasis) |
| 52 weeks |
| Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma) | 52 weeks |
| sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma) | 52 weeks |
| Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma) | 52 weeks |
| Incidence and types of adverse events and adverse reactions | 52 weeks |
| Laboratory values and vital signs | 52 weeks |
| Profiles of pharmacokinetics | Concentration of KHK4827 in serum | 52 weeks |
| Development of anti-KHK4827 antibody | 52 weeks |