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

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.

Study Overview

• Status: Recruiting
• Conditions: Prurigo Nodularis (PN)
• Intervention / Treatment: Drug: Dupilumab

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Marjolein de Bruin-Weller, Professor; Phone Number: 000; Email: m.s.debruin-weller@umcutrecht.nl

Study Locations

• Netherlands
  • Utrecht
    • Utrecht, Utrecht, Netherlands
      • Recruiting
      • University Medical Center Utrecht
      • Contact: Marjolein de Bruin-Weller, Professor; Phone Number: 000; Email: m.s.debruin-weller@umcutrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Secondary and tertiary care clinics

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dupilumab; prurigo nodularis
• Additional Relevant MeSH Terms: dupilumab
• Other Study ID Numbers: 12-407; 2023ESR0000155 (Other Identifier: Sanofi)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No