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RecruitingNCT07276425Updated Dec 18, 2025

Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo Nodularis

An observational study in Prurigo Nodularis (PN), sponsored by UMC Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by UMC Utrecht · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prurigo Nodularis (PN)

Keywords

  • prurigo nodularis
  • dupilumab
03

In context

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Secondary and tertiary care clinics

Inclusion criteria

  • Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment

Exclusion criteria

Exclusion Criteria:

  • Unwilling to participate in the BioDay registry
  • (For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
52 Weeks
Patient registry
Yes
Biospecimen retention
Samples with dna

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.

    Also known as: Dupixent

06

What researchers measure

Primary outcomes

  1. Peak Pruritus NRS (PP-NRS)

    Peak pruritus NRS of the past 24 hours

    Time frame: From enrollment to 52 weeks of treatment

  2. 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 treatment

  3. Drug survival

    Duration of dupilumab treatment, reasons for discontinuation

    Time frame: From enrollment to 52 weeks of treatment

  4. Adverse events

    Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events

    Time frame: From enrollment to 52 weeks of treatment

  5. Skin homing T cell subtypes

    Time frame: Up to 52 weeks of treatment

  6. Serum levels of relevant proteins

    Time frame: Up to 52 weeks of treatment

  7. Systemic epigenetic changes

    Time frame: Up to 52 weeks of treatment

07

Study locations

1 of 1 sites recruiting
  • University Medical Center Utrecht
    Utrecht, Utrecht, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07276425
Lead sponsor
UMC Utrecht
Collaborators
Sanofi
Responsible party
Dr M.S. de Bruin-Weller (Professor, UMC Utrecht) — Principal investigator
First posted
Dec 11, 2025
Start date
Jun 1, 2025
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Dec 18, 2025

Study contacts

Marjolein de Bruin-Weller, Professor
Contact
m.s.debruin-weller@umcutrecht.nl
000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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