Prurigo Nodularis (PN)NCT07276425
Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo Nodularis
An observational study of Prurigo Nodularis (PN), run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis (PN)
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2025to 1 Jun 2028
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary and tertiary care clinics
Who may be able to join
- Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment
Who cannot join
- Unwilling to participate in the BioDay registry
- (For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht
Marjolein de Bruin-Weller, Professor, 000, m.s.debruin-weller@umcutrecht.nl
About this study
Official title: 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.
- Conditions
- Prurigo Nodularis (PN)
- Being tested
- Dupilumab
- Keywords
- prurigo nodularis, dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Pruritus NRS (PP-NRS)
Peak pruritus NRS of the past 24 hours
Measured: 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
Measured: From enrollment to 52 weeks of treatment
Drug survival
Duration of dupilumab treatment, reasons for discontinuation
Measured: From enrollment to 52 weeks of treatment
Adverse events
Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events
Measured: From enrollment to 52 weeks of treatment
Skin homing T cell subtypes
Measured: Up to 52 weeks of treatment
Serum levels of relevant proteins
Measured: Up to 52 weeks of treatment
Systemic epigenetic changes
Measured: Up to 52 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo Nodularis (PN)Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Dr M.S. de Bruin-Weller, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276425
- Sponsor's protocol ID
- 12-407
- Other IDs
- 2023ESR0000155
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients
- ClinicalTrials.gov ID
- NCT07276425
- Acronym / sponsor ID
- 12-407
- Conditions
- Prurigo Nodularis (PN)
- Keywords
- prurigo nodularis, dupilumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary and tertiary care clinics
Key inclusion criteria (1 listed)
- Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment
Key exclusion criteria (2 listed)
- Unwilling to participate in the BioDay registry
- (For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentIn 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. | Drug | – |
Primary outcome
Peak Pruritus NRS (PP-NRS)
Time frame: From enrollment to 52 weeks of treatment
Peak pruritus NRS of the past 24 hours
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
Drug survival
Time frame: From enrollment to 52 weeks of treatment
Duration of dupilumab treatment, reasons for discontinuation
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
Skin homing T cell subtypes
Time frame: Up to 52 weeks of treatment
Serum levels of relevant proteins
Time frame: Up to 52 weeks of treatment
Systemic epigenetic changes
Time frame: Up to 52 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prurigo Nodularis (PN), run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjolein de Bruin-Weller, Professor (000, m.s.debruin-weller@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Pruritus NRS (PP-NRS) (time frame: From enrollment to 52 weeks of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.