Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo Nodularis
ConditionPrurigo Nodularis (PN)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment
Disqualifiers
Unwilling to participate in the BioDay registry
(For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
Trial population
Secondary and tertiary care clinics
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dupilumab
DrugIn 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Peak Pruritus NRS (PP-NRS)
Peak pruritus NRS of the past 24 hours
Time frame
From enrollment to 52 weeks of treatment2
Investigator Global Assessment scale of Prurigo Nodularis stage (IGA-PN)
Investigator Global Assessment scale of Prurigo Nodularis stage
Time frame
From enrollment to 52 weeks of treatment3
Drug survival
Duration of dupilumab treatment, reasons for discontinuation
Time frame
From enrollment to 52 weeks of treatment4
Adverse events
Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events
Time frame
From enrollment to 52 weeks of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov