Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study (NCT05991323) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
United States, Canada, China100 participantsStarted 2023-12-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment
Timeframe: At baseline
2
Frequency of reasons for dupilumab treatment modifications with the description of the modified treatment
Timeframe: From baseline up to month 18
3
Proportion of patients who discontinued dupilumab
Timeframe: From baseline up to month 18
4
Frequency of reasons for dupilumab treatment discontinuation