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Terminated early due to lack of expected efficacy. Three participants were enrolled but none completed the study.
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The goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. Approximately 25 subjects will be included in the study and receive Deucravacitinib 6mg per day for four months. This study will begin June 2025 and is expected to last 14 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib treatment | Experimental | 25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | 25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint | The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPPASI) at W16. | From enrollment to the end of treatment at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Deucravacitinib on overall severity of palmoplantar pustulosis | Mean change in erythema and pustules from Baseline to week 16 will be evaluated by Palmoplantar Pustular Physician's Global Assessment (PPPGA). | From enrollment to the end of treatment at 16 weeks |
| Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Deucravacitinib in patients with palmoplantar pustulosis | To evaluate the tolerability of Deucravacitinib in patients with palmoplantar pustulosis through assessment of adverse events at every visit from Baseline to week 4, 8,12, 16. | From enrollment to the end of treatment at 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | 100034 | China |
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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 |
|---|---|
| C000628674 | deucravacitinib |
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Mean change in quality of life from Baseline to week 16 will be evaluated by Dermatology Life Quality Index (DLQI) |
| From enrollment to the end of treatment at 16 weeks |