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

Study on the Use of Dupilumab for Prurigo Nodularis

Recruiting
18 years or above
All
Phase N/A
550 participants needed
1 Location

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 60 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 29 Feb 2024. Study ID: NCT05991323

This study investigates the real-world use of an investigational medication in adults with prurigo nodularis (PN). Prurigo nodularis is a skin condition characterized by itchy, hard bumps on the skin. The purpose of this study is to observe how the investigational medication is used and how it works in everyday settings for people with PN.

Participants will have their medical history and disease characteristics recorded. The study will also evaluate the long-term effects of the investigational medication. Participants will need to answer questionnaires related to their treatment and health.

  • Who can participate: Adults aged 18 years or older who have been prescribed the investigational medication for prurigo nodularis can participate. They must be able to understand and complete study-related questionnaires and provide informed consent.
  • Study details: Participants will be observed based on their treatment with the investigational medication for prurigo nodularis. They will complete questionnaires about their health and treatment experiences. The study does not involve any investigational treatment interventions.
  • Study Timelines: The study will last 60 months.

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