Status:
ACTIVE_NOT_RECRUITING
Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 22 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05991323
Start Date
December 12 2023
End Date
September 22 2026
Last Update
September 16 2025
Active Locations (49)
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1
Medical Dermatology Specialists Site Number : 8400005
Phoenix, Arizona, United States, 85006-2754
2
Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024
Phoenix, Arizona, United States, 85008-3884
3
Center for Dermatology Clinical Research- Site Number : 8400002
Fremont, California, United States, 94538
4
Halcyon Dermatology- Site Number : 8400023
Laguna Hills, California, United States, 92653