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

Last updated: February 21, 2024
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eczema (Atopic Dermatitis - Pediatric)

Dermatitis, Atopic

Prurigo Nodularis

Treatment

Dupilumab SAR231893 (REGN668)

Clinical Study ID

NCT06087627
OBS17933
U1111-1290-5823
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 withinthe last 7 days for moderate to severe prurigo nodularis according to the prescribinginformation/Summary of Product Characteristics (SmPC)
  • Patients who received the initial diagnosis of PN

Exclusion

Exclusion Criteria:

  • Patients who have a contraindication to dupilumab according to the current prescribinginformation 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 limitthe patient´s ability to complete questionnaires or to participate in this study orimpact the interpretation of the results
  • Participation in an ongoing interventional or observational study that might, in thetreating physician´s opinion, influence the assessments for the current study The above information is not intended to contain all considerations relevant to a potentialparticipation in a clinical trial.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Dupilumab SAR231893 (REGN668)
Phase:
Study Start date:
December 27, 2023
Estimated Completion Date:
December 28, 2026

Study 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 after dupilumab initiation, respectively.

Connect with a study center

  • Investigational Site Number: 013

    Adernach, 56626
    Germany

    Active - Recruiting

  • Investigational Site Number: 002

    Berlin, 13507
    Germany

    Active - Recruiting

  • Investigational site number: 001

    Berlin, 12203
    Germany

    Active - Recruiting

  • Investigational Site Number: 023

    Chemnitz, 09117
    Germany

    Active - Recruiting

  • Investigational Site Number: 005

    Düren, 52349
    Germany

    Active - Recruiting

  • Investigational Site Number: 004

    Düsseldorf, 40219
    Germany

    Active - Recruiting

  • Investigational Site Number: 007

    Hamburg, 22391
    Germany

    Active - Recruiting

  • Investigational Site Number: 016

    Leipzig, 04371
    Germany

    Active - Recruiting

  • Investigational Site Number: 031

    Mainz, 55128
    Germany

    Active - Recruiting

  • Investigational Site Number: 022

    Potsdam, 14467
    Germany

    Active - Recruiting

  • Investigational Site Number: 024

    Potsdam, 14469
    Germany

    Active - Recruiting

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