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NCT Number: NCT07276425

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

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.

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Key information

Conditions

Prurigo Nodularis (PN)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, Netherlands

Location status: Recruiting

Location contact

Marjolein de Bruin-Weller, Professor

CONTACT

[email protected]

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dupilumab

Drug

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.

Other names: Dupixent

Primary outcomes

  1. Peak Pruritus NRS (PP-NRS)

    Time frame: From enrollment to 52 weeks of treatment

    Peak pruritus NRS of the past 24 hours

  2. Investigator Global Assessment scale of Prurigo Nodularis stage (IGA-PN)

    Time frame: From enrollment to 52 weeks of treatment

    Investigator Global Assessment scale of Prurigo Nodularis stage

  3. Drug survival

    Time frame: From enrollment to 52 weeks of treatment

    Duration of dupilumab treatment, reasons for discontinuation

  4. Adverse events

    Time frame: From enrollment to 52 weeks of treatment

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Marjolein de Bruin-Weller, Professor

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Sanofi

Registry information

Official study title

Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 11, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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