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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
Sponsor: Sanofi
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 to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes injuries to the skin. In recent years, number of studies evaluating PN, the affected population and the disease burden has increased but PN remains still understudied. This non-interventional study is intended to describe the long-term effectiveness of dupilumab (Dupixent®) in participants aged 18 years or older and suffering from moderate-to-severe PN who receive dupilumab for PN treatment in a real-world setting in Germany according to the prescribing information (Summary of Product Characteristics \[SmPC\]). The decision to initiate dupilumab treatment is made by the treating physician and participant according to the participant's medical need and to the standard of best medical practice. This decision is made independently and before data inclusion in this non-interventional study.
Official title: Prospective, Non-interventional Observational Study to Characterize Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2023-12-27
Completion Date
2026-12-28
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
Dupilumab SAR231893 (REGN668)
Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)
Locations (11)
Investigational Site Number: 013
Adernach, Germany
Investigational site number: 001
Berlin, Germany
Investigational Site Number: 002
Berlin, Germany
Investigational Site Number: 023
Chemnitz, Germany
Investigational Site Number: 005
Düren, Germany
Investigational Site Number: 004
Düsseldorf, Germany
Investigational Site Number: 007
Hamburg, Germany
Investigational Site Number: 016
Leipzig, Germany
Investigational Site Number: 031
Mainz, Germany
Investigational Site Number: 022
Potsdam, Germany
Investigational Site Number: 024
Potsdam, Germany