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

NCT ID: NCT07276425

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prurigo Nodularis (PN)

Keywords

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prurigo nodularis dupilumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dupilumab

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.

Intervention Type DRUG

Other Intervention Names

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Dupixent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Dr M.S. de Bruin-Weller

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marjolein de Bruin-Weller, Professor

Role: CONTACT

Phone: 000

Email: [email protected]

Facility Contacts

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Marjolein de Bruin-Weller, Professor

Role: primary

Other Identifiers

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2023ESR0000155

Identifier Type: OTHER

Identifier Source: secondary_id

12-407

Identifier Type: -

Identifier Source: org_study_id