RecruitingNCT06087627

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

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


Sponsor

Sanofi

Enrollment

150 participants

Start Date

Dec 27, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

DRUGDupilumab 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

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NCT06087627


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