Actively Recruiting

Age: 18Years +
All Genders
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

Led by Sanofi · Updated on 2025-08-13

150

Participants Needed

11

Research Sites

156 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants at least 18 years of age at baseline visit
  • Signed written informed consent
  • New initiation with dupilumab or treatment started within last 7 days for moderate to severe prurigo nodularis as per prescribing information
  • Patients with a confirmed diagnosis of prurigo nodularis
Not Eligible

You will not qualify if you...

  • Contraindication to dupilumab according to current prescribing information
  • Treated with dupilumab for more than 7 days
  • Any acute or chronic condition limiting ability to complete questionnaires or participate, as judged by treating physician
  • Participation in another ongoing interventional or observational study that may influence assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Investigational Site Number: 013

Adernach, Germany, 56626

Actively Recruiting

2

Investigational site number: 001

Berlin, Germany, 12203

Actively Recruiting

3

Investigational Site Number: 002

Berlin, Germany, 13507

Actively Recruiting

4

Investigational Site Number: 023

Chemnitz, Germany, 09117

Actively Recruiting

5

Investigational Site Number: 005

Düren, Germany, 52349

Actively Recruiting

6

Investigational Site Number: 004

Düsseldorf, Germany, 40219

Actively Recruiting

7

Investigational Site Number: 007

Hamburg, Germany, 22391

Actively Recruiting

8

Investigational Site Number: 016

Leipzig, Germany, 04371

Actively Recruiting

9

Investigational Site Number: 031

Mainz, Germany, 55128

Actively Recruiting

10

Investigational Site Number: 022

Potsdam, Germany, 14467

Actively Recruiting

11

Investigational Site Number: 024

Potsdam, Germany, 14469

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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