Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients
Sponsor study identifier
Secondary identifiers
OTHER · Sanofi
observational
40
1 country
1
Study Start
June 1, 2025
Actual (reported)Primary Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2025
Actual (reported)November 28, 2025
Actual (reported)December 11, 2025
Actual (reported)June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Secondary and tertiary care clinics
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Blood samples and skin biopsies
First Submitted
November 28, 2025
First Posted
December 11, 2025
Study Start
June 1, 2025
Actual (reported)Primary Completion
June 1, 2028
EstimatedA Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
Serum levels of relevant proteins
Up to 52 weeks of treatment
Systemic epigenetic changes
Up to 52 weeks of treatment
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 18, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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