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RECRUITING
NCT06087627

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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