Prurigo Nodularis (PN)
Conditions
Keywords
prurigo nodularis, dupilumab
Brief summary
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.
Interventions
DRUGDupilumab
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.
Sponsors
Sanofi
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment
Exclusion criteria
* Unwilling to participate in the BioDay registry * (For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pruritus NRS (PP-NRS) | From enrollment to 52 weeks of treatment | Peak pruritus NRS of the past 24 hours |
| Investigator Global Assessment scale of Prurigo Nodularis stage (IGA-PN) | From enrollment to 52 weeks of treatment | Investigator Global Assessment scale of Prurigo Nodularis stage |
| Drug survival | From enrollment to 52 weeks of treatment | Duration of dupilumab treatment, reasons for discontinuation |
| Adverse events | From enrollment to 52 weeks of treatment | Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events |
| 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 | — |
Countries
Netherlands
Contacts
Primary ContactMarjolein de Bruin-Weller, Professor
Outcome results
None listed