Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
NCT ID: NCT05991323
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2023-12-12
2026-09-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patient with prurigo nodularis
Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study
Dupilumab
Injection solution; subcutaneous
Interventions
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Dupilumab
Injection solution; subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Medical Dermatology Specialists Site Number : 8400005
Phoenix, Arizona, United States
Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024
Phoenix, Arizona, United States
Center for Dermatology Clinical Research- Site Number : 8400002
Fremont, California, United States
Halcyon Dermatology- Site Number : 8400023
Laguna Hills, California, United States
Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015
Rancho Santa Margarita, California, United States
Golden State Dermatology- Site Number : 8400014
Walnut Creek, California, United States
Total Vein And Skin, LLC- Site Number : 8400019
Boynton Beach, Florida, United States
GSI Clinical Research- Site Number : 8400017
Margate, Florida, United States
Allergy Center at Brookstone Research - Centricity Research - PPDS- Site Number : 8400025
Columbus, Georgia, United States
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave- Site Number : 8400003
Indianapolis, Indiana, United States
Oakland Hills Dermatology - 3400 Auburn Rd- Site Number : 8400007
Auburn Hills, Michigan, United States
Derm Institute of Western Michigan- Site Number : 8400034
Caledonia, Michigan, United States
Dermatology Associates Western Michigan- Site Number : 8400033
Grand Rapids, Michigan, United States
U.S. Dermatology Partners Lee's Summit- Site Number : 8400016
Lee's Summit, Missouri, United States
University of Nebraska - Lauritzen Outpatient Center- Site Number : 8400029
Omaha, Nebraska, United States
Vivida Dermatology - Flamingo- Site Number : 8400013
Las Vegas, Nevada, United States
Las Vegas Dermatology- Site Number : 8400027
Las Vegas, Nevada, United States
Duke Dermatology Clinic- Site Number : 8400026
Durham, North Carolina, United States
Medical University of South Carolina (MUSC) - PPDS- Site Number : 8400001
Charleston, South Carolina, United States
North Texas Center for Clinical Research- Site Number : 8400012
Frisco, Texas, United States
U.S. Dermatology Partners Longview- Site Number : 8400032
Longview, Texas, United States
Texas Tech University Health Sciences Center-125 W Hague Rd- Site Number : 8400010
Lubbock, Texas, United States
West Virginia Research Institute- Site Number : 8400030
Morgantown, West Virginia, United States
Investigational Site Number : 1240009
Calgary, Alberta, Canada
Investigational Site Number : 1240007
Edmonton, Alberta, Canada
Investigational Site Number : 1240012
Surrey, British Columbia, Canada
Investigational Site Number : 1240006
Fredericton, New Brunswick, Canada
Investigational Site Number : 1240004
Ajax, Ontario, Canada
Investigational Site Number : 1240003
Barrie, Ontario, Canada
Investigational Site Number : 1240011
London, Ontario, Canada
Investigational Site Number : 1240002
Newmarket, Ontario, Canada
Investigational Site Number : 1240005
Toronto, Ontario, Canada
Investigational Site Number : 1240010
Waterloo, Ontario, Canada
Investigational Site Number : 1560009
Guangzhou, Guangdong, China
Investigational Site Number : 1560004
Xi'an, Shaanxi, China
Investigational Site Number : 1560003
Jinan, Shandong, China
Investigational Site Number : 1560008
Hangzhou, Zhejiang, China
Investigational Site Number : 1560010
Wenzhou, Zhejiang, China
Investigational Site Number : 1560007
Beijing, , China
Investigational Site Number : 1560005
Beijing, , China
Investigational Site Number : 1560006
Shanghai, , China
Investigational Site Number : 1560002
Shenzhen, , China
Investigational Site Number : 2500005
Brest, Finistère, France
Investigational Site Number : 2500001
Nantes, , France
Investigational Site Number : 3920001
Obihiro, Hokkaido, Japan
Investigational Site Number : 3920003
Kyoto, , Japan
Investigational Site Number : 3920004
Matsudo, , Japan
Investigational Site Number : 5280001
Bergen op Zoom, North Brabant, Netherlands
Investigational Site Number : 5280002
Hoofddorp, North Holland, Netherlands
Countries
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Other Identifiers
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U1111-1288-8567
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS17721
Identifier Type: -
Identifier Source: org_study_id
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