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The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed with moderate-to-severe plaque psoriasis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 24 weeks from treatment initiation | |
| Number of participants with adverse drug reactions (ADRs) | Up to 24 weeks from treatment initiation | |
| Number of participants with serious adverse events (SAEs) | Up to 24 weeks from treatment initiation | |
| Number of participants with serious adverse drug reactions (SADRs) | Up to 24 weeks from treatment initiation | |
| Number of participants with unexpected adverse events (AEs) | Up to 24 weeks from treatment initiation | |
| Number of participants with unexpected adverse drug reactions (ADRs) | Up to 24 weeks from treatment initiation | |
| Number of participants with unexpected serious adverse events (SAEs) | Up to 24 weeks from treatment initiation | |
| Number of participants with unexpected serious adverse drug reactions (SADRs) | Up to 24 weeks from treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1 | At Week 16 and/or Week 24 post treatment initiation | |
| Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult patients in Korea who have been diagnosed with moderate-to-severe plaque psoriasis and have been prescribed treatment with deucravacitinib according to the approved product label.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Withdrawn | Seoul | 06234 | South Korea | ||
| Novotech Laboratory Korea Co., Ltd. |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| At Week 16 and/or Week 24 post treatment initiation |
| Recruiting |
| Seoul |
| 06234 |
| South Korea |
|