Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study

Investigational Medication for Prurigo Nodularis

Recruiting
18 years or above
All
Phase N/A
300 participants needed
31 Locations

Study Overview

This study is a prospective, multinational, observational investigation designed to elucidate the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients diagnosed with prurigo nodularis (PN).

The primary objective of this study is to comprehensively characterize the real-world usage of dupilumab for the management of PN.

In addition to this, the study aims to achieve several secondary objectives, including a detailed assessment of the medical history, socio-demographic and disease characteristics of dupilumab-treated PN patients, as well as the evaluation of the long-term real-world effectiveness of dupilumab therapy for PN.

Study Details

The follow-up period will be 36 months or until death, loss to follow-up, or withdrawal, whichever comes first.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prurigo Nodularis
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Patients aged 18 years or older at the time of informed consent.
  • Physician decision to treat the patient with dupilumab for prurigo nodularis (according to the country-specific prescribing information) made prior to and independently of the patient's participation in the study.
  • Patients able to understand and complete study-related questionnaires.
  • Patients provide voluntary informed consent to participate in the study before inclusion in the study.

Exclusion Criteria:

  • Patients who have a contraindication to dupilumab according to the country-specific prescribing information label.
  • Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of visits and assessments.
  • Patients currently participating in any interventional clinical trial.
  • Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.

Updated on 10 Feb 2025. Study ID: NCT05991323

This study investigates the real-world use of an investigational medication in adults with prurigo nodularis, a skin condition that causes itchy lumps. The purpose is to understand how the medication is used in everyday settings.

Participants will have their medical history and disease characteristics assessed. They will also complete questionnaires to help evaluate the long-term effectiveness of the treatment. No active treatment or placebo will be given as part of this study.

  • Who can participate: Adults aged 18 years or older who have been prescribed the investigational medication for prurigo nodularis by their doctor can participate. Participants must be able to complete study questionnaires and provide informed consent.
  • Study details: Participants will provide information about their medical history and disease characteristics. They will complete questionnaires during the study period.
  • Study Timelines: The study will last 36 months.

Find a Study Location to Connect

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site