Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo Nodularis
Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients
2 other identifiers
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 28, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
December 18, 2025
December 1, 2025
3 years
November 28, 2025
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Interventions
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.
Eligibility Criteria
Secondary and tertiary care clinics
You may qualify if:
- Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment
You may not qualify if:
- Unwilling to participate in the BioDay registry
- (For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Sanoficollaborator
Study Sites (1)
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Biospecimen
Blood samples and skin biopsies
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 52 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2025
First Posted
December 11, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share