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| ID | Type | Description | Link |
|---|---|---|---|
| 2023ESR0000155 | Other Identifier | Sanofi |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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With the arrival of dupilumab as the first available targeted therapy for PN, there is an unmet need for real-world data and translational research on the working mechanism of dupilumab on PN, to optimize individualized targeted treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | In the Netherlands, the standard care for patients with moderate-to-severe prurigo nodularis who have failed or are contraindicated to conventional systemic immunosuppressive treatments consists of 300 mg of dupilumab administered subcutaneously every two weeks, following a loading dose of 600 mg administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Pruritus NRS (PP-NRS) | Peak pruritus NRS of the past 24 hours | From enrollment to 52 weeks of treatment |
| Investigator Global Assessment scale of Prurigo Nodularis stage (IGA-PN) | Investigator Global Assessment scale of Prurigo Nodularis stage | From enrollment to 52 weeks of treatment |
| Drug survival | Duration of dupilumab treatment, reasons for discontinuation | From enrollment to 52 weeks of treatment |
| Adverse events | Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events | From enrollment to 52 weeks of treatment |
| Skin homing T cell subtypes | Up to 52 weeks of treatment | |
| Serum levels of relevant proteins | Up to 52 weeks of treatment | |
| Systemic epigenetic changes | Up to 52 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Secondary and tertiary care clinics
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjolein de Bruin-Weller, Professor | Contact | 000 | m.s.debruin-weller@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Recruiting | Utrecht | Utrecht | Netherlands |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Blood samples and skin biopsies