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| ID | Type | Description | Link |
|---|---|---|---|
| Parsaclisib | Other Identifier | Incyte Corporation |
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The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.
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The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parsaclisib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Parsaclisib administered orally once daily at the cohort-specified dose level. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Parsaclisib | Maximum observed concentration. | Up to 6 weeks |
| tmax of Parsaclisib | Time to maximum concentration. | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | Incyte Corporation | Study Director |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| C000656179 | parsaclisib |
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| Cmin of Parsaclisib | Minimum observed concentration over the dose interval. | Up to 6 weeks |
| AUC0-t of Parsaclisib | Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t. | Up to 6 weeks |
| CL/F of Parsaclisib | Apparent oral dose clearance. | Up to 6 weeks |
| D007154 | Immune System Diseases |