Dupilumab for early and long-term symptom relief and immune changes in prurigo nodularis
Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients
This project will try dupilumab in adults with moderate-to-severe prurigo nodularis to see if it reduces itching and nodules and causes measurable immune changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Utrecht, Utrecht) |
| Trial ID | NCT07276425 on ClinicalTrials.gov |
What this trial studies
This is an observational, real-world study following adults with moderate-to-severe prurigo nodularis who start treatment with dupilumab. Patients are enrolled in the BioDay registry and some may consent to provide samples to the UMC Utrecht Biobank for translational analyses. The study will track early and long-term clinical outcomes (symptoms and lesion changes) alongside immune markers to understand how dupilumab acts in routine clinical care. Findings aim to link clinical response with immune changes to help personalize treatment.
Who should consider this trial
Good fit: Adults with moderate-to-severe prurigo nodularis who are beginning dupilumab treatment and are willing to join the BioDay registry (and optionally the Biobank) are ideal candidates.
Not a fit: Patients with mild prurigo nodularis, those not starting dupilumab, or those unwilling to participate in the registry or provide samples for translational analyses are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the study could help clinicians better predict who will benefit from dupilumab and tailor treatment plans for longer-lasting symptom control.
How similar studies have performed: Randomized trials and clinical reports have shown dupilumab can reduce itch and lesions in prurigo nodularis, but detailed real-world and immune-mechanism data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Utrecht, Utrecht
- University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marjolein de Bruin-Weller, Professor
- Email: m.s.debruin-weller@umcutrecht.nl
- Phone: 000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.