Status:
RECRUITING
A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine
Lead Sponsor:
Sanofi
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18+ years
Brief Summary
Prurigo nodularis (PN) is a skin disease characterized by the presence of single to multiple symmetrically distributed, intensively itching nodules. The main symptom is uncontrollable itching leading ...
Detailed Description
The individual observational period is planned to be up to 2 years, with assessments at baseline, one month after baseline and afterwards, every 3 months in the 1st and every 6 months in the 2nd year ...
Eligibility Criteria
Inclusion
- Participants at least 18 years of age at baseline visit
- Signed written informed consent
- New initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the prescribing information/Summary of Product Characteristics (SmPC)
- Patients who received the initial diagnosis of PN
Exclusion
- Patients who have a contraindication to dupilumab according to the current prescribing information label/SmPC
- Patients who have been treated for more than 7 days with dupilumab
- Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results
- Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 28 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06087627
Start Date
December 27 2023
End Date
December 28 2026
Last Update
August 13 2025
Active Locations (11)
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1
Investigational Site Number: 013
Adernach, Germany, 56626
2
Investigational site number: 001
Berlin, Germany, 12203
3
Investigational Site Number: 002
Berlin, Germany, 13507
4
Investigational Site Number: 023
Chemnitz, Germany, 09117