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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000782-40 | EudraCT Number | ||
| U1111-1284-2254 | Other Identifier | World Health Organization (WHO) |
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The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema.
Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream.
The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | Twice-daily topical application for 8 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib | Drug | Cream for topical application 20 mg/g |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12). | 0-12 hours post dose at Day 1 and Day 8 | |
| Maximum observed concentration (Cmax) at Day 1 and at Day 8 (0-12 hours post-dose). | Day 1 and at Day 8 (0-12 hours post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum observed concentration (tmax) at Day 1 and Day 8 (0-12 hours post-dose). | Day 1 and Day 8 (0-12 hours post-dose). | |
| Terminal elimination half-life (t1/2) at Day 8. | Day 8. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Investigational Site | Hamburg | 20095 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40525591 | Derived | Thaci D, Gooderham M, Lovato P, Madsen DE, Soehoel A, Bissonnette R. Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema. J Eur Acad Dermatol Venereol. 2025 Sep;39(9):1612-1621. doi: 10.1111/jdv.20777. Epub 2025 Jun 17. |
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| ID | Term |
|---|---|
| C000621572 | delgocitinib |
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| Number of treatment-emergent adverse events (AEs) from baseline to Day 22 per subject. |
| Baseline to Day 22 |