Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
Observational Study of Prurigo Nodularis and Treatment Patterns
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
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Age: 18 years or above
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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.
This study investigates the real-world effectiveness and treatment patterns of an investigational medication in adult patients diagnosed with prurigo nodularis (PN). Prurigo nodularis is a skin condition characterized by hard, itchy bumps. The purpose of this observational study is to understand how the investigational medication is used in managing PN in everyday settings.
Participants in the study will be observed over a period to collect data on their treatment with the investigational medication. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
- Who can participate: Adults aged 18 years or older who have been prescribed the investigational medication for prurigo nodularis by their physician can participate. Participants must be able to understand and complete study-related questionnaires and provide informed consent.
- Study details: Participants will be observed to gather information about their treatment with dupilumab. This includes assessments of their medical history and disease characteristics without altering their treatment routine.
- Study timelines: The study will last 60 months.
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