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

NCT05991323 · tracked via the Priya Life Science China tracker

Sponsor

Sanofi

Phase

Observational

Started

2023-12-12

Last updated

2025-09-16

Condition(s) studied

Prurigo Nodularis

Investigational drug(s) / intervention(s)

Dupilumab

Dupilumab: Injection solution; subcutaneous

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment — At baseline
Frequency of reasons for dupilumab treatment modifications with the description of the modified treatment — From baseline up to month 18
Proportion of patients who discontinued dupilumab — From baseline up to month 18
Frequency of reasons for dupilumab treatment discontinuation — From baseline up to month 18
Proportion of patients hospitalized due to PN — From baseline up to month 18

Trial sites (49)

Facility	City	Region
Medical Dermatology Specialists Site Number : 8400005	Phoenix	Arizona
Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024	Phoenix	Arizona
Center for Dermatology Clinical Research- Site Number : 8400002	Fremont	California
Halcyon Dermatology- Site Number : 8400023	Laguna Hills	California
Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015	Rancho Santa Margarita	California
Golden State Dermatology- Site Number : 8400014	Walnut Creek	California
Total Vein And Skin, LLC- Site Number : 8400019	Boynton Beach	Florida
GSI Clinical Research- Site Number : 8400017	Margate	Florida
Allergy Center at Brookstone Research - Centricity Research - PPDS- Site Number : 8400025	Columbus	Georgia
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave- Site Number : 8400003	Indianapolis	Indiana
Oakland Hills Dermatology - 3400 Auburn Rd- Site Number : 8400007	Auburn Hills	Michigan
Derm Institute of Western Michigan- Site Number : 8400034	Caledonia	Michigan
Dermatology Associates Western Michigan- Site Number : 8400033	Grand Rapids	Michigan
U.S. Dermatology Partners Lee's Summit- Site Number : 8400016	Lee's Summit	Missouri
University of Nebraska - Lauritzen Outpatient Center- Site Number : 8400029	Omaha	Nebraska
Vivida Dermatology - Flamingo- Site Number : 8400013	Las Vegas	Nevada
Las Vegas Dermatology- Site Number : 8400027	Las Vegas	Nevada
Duke Dermatology Clinic- Site Number : 8400026	Durham	North Carolina
Medical University of South Carolina (MUSC) - PPDS- Site Number : 8400001	Charleston	South Carolina
North Texas Center for Clinical Research- Site Number : 8400012	Frisco	Texas
U.S. Dermatology Partners Longview- Site Number : 8400032	Longview	Texas
Texas Tech University Health Sciences Center-125 W Hague Rd- Site Number : 8400010	Lubbock	Texas
West Virginia Research Institute- Site Number : 8400030	Morgantown	West Virginia
Investigational Site Number : 1240009	Calgary	Alberta
Investigational Site Number : 1240007	Edmonton	Alberta
Investigational Site Number : 1240012	Surrey	British Columbia
Investigational Site Number : 1240006	Fredericton	New Brunswick
Investigational Site Number : 1240004	Ajax	Ontario
Investigational Site Number : 1240003	Barrie	Ontario
Investigational Site Number : 1240011	London	Ontario
Investigational Site Number : 1240002	Newmarket	Ontario
Investigational Site Number : 1240005	Toronto	Ontario
Investigational Site Number : 1240010	Waterloo	Ontario
Investigational Site Number : 1560009	Guangzhou	Guangdong
Investigational Site Number : 1560004	Xi'an	Shaanxi
Investigational Site Number : 1560003	Jinan	Shandong
Investigational Site Number : 1560008	Hangzhou	Zhejiang
Investigational Site Number : 1560010	Wenzhou	Zhejiang
Investigational Site Number : 1560007	Beijing	China
Investigational Site Number : 1560005	Beijing	China

+ 9 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

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Other trials for the same condition

Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis Recruiting

Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05991323 on ClinicalTrials.gov ↗ ← All trials in China