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

NCT ID: NCT05991323

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-12

Study Completion Date

2026-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prurigo Nodularis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type DRUG

Injection solution; subcutaneous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dupilumab

Injection solution; subcutaneous

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DUPIXENT SAR231893

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Dermatology Specialists Site Number : 8400005

Phoenix, Arizona, United States

Site Status

Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024

Phoenix, Arizona, United States

Site Status

Center for Dermatology Clinical Research- Site Number : 8400002

Fremont, California, United States

Site Status

Halcyon Dermatology- Site Number : 8400023

Laguna Hills, California, United States

Site Status

Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015

Rancho Santa Margarita, California, United States

Site Status

Golden State Dermatology- Site Number : 8400014

Walnut Creek, California, United States

Site Status

Total Vein And Skin, LLC- Site Number : 8400019

Boynton Beach, Florida, United States

Site Status

GSI Clinical Research- Site Number : 8400017

Margate, Florida, United States

Site Status

Allergy Center at Brookstone Research - Centricity Research - PPDS- Site Number : 8400025

Columbus, Georgia, United States

Site Status

Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave- Site Number : 8400003

Indianapolis, Indiana, United States

Site Status

Oakland Hills Dermatology - 3400 Auburn Rd- Site Number : 8400007

Auburn Hills, Michigan, United States

Site Status

Derm Institute of Western Michigan- Site Number : 8400034

Caledonia, Michigan, United States

Site Status

Dermatology Associates Western Michigan- Site Number : 8400033

Grand Rapids, Michigan, United States

Site Status

U.S. Dermatology Partners Lee's Summit- Site Number : 8400016

Lee's Summit, Missouri, United States

Site Status

University of Nebraska - Lauritzen Outpatient Center- Site Number : 8400029

Omaha, Nebraska, United States

Site Status

Vivida Dermatology - Flamingo- Site Number : 8400013

Las Vegas, Nevada, United States

Site Status

Las Vegas Dermatology- Site Number : 8400027

Las Vegas, Nevada, United States

Site Status

Duke Dermatology Clinic- Site Number : 8400026

Durham, North Carolina, United States

Site Status

Medical University of South Carolina (MUSC) - PPDS- Site Number : 8400001

Charleston, South Carolina, United States

Site Status

North Texas Center for Clinical Research- Site Number : 8400012

Frisco, Texas, United States

Site Status

U.S. Dermatology Partners Longview- Site Number : 8400032

Longview, Texas, United States

Site Status

Texas Tech University Health Sciences Center-125 W Hague Rd- Site Number : 8400010

Lubbock, Texas, United States

Site Status

West Virginia Research Institute- Site Number : 8400030

Morgantown, West Virginia, United States

Site Status

Investigational Site Number : 1240009

Calgary, Alberta, Canada

Site Status

Investigational Site Number : 1240007

Edmonton, Alberta, Canada

Site Status

Investigational Site Number : 1240012

Surrey, British Columbia, Canada

Site Status

Investigational Site Number : 1240006

Fredericton, New Brunswick, Canada

Site Status

Investigational Site Number : 1240004

Ajax, Ontario, Canada

Site Status

Investigational Site Number : 1240003

Barrie, Ontario, Canada

Site Status

Investigational Site Number : 1240011

London, Ontario, Canada

Site Status

Investigational Site Number : 1240002

Newmarket, Ontario, Canada

Site Status

Investigational Site Number : 1240005

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240010

Waterloo, Ontario, Canada

Site Status

Investigational Site Number : 1560009

Guangzhou, Guangdong, China

Site Status

Investigational Site Number : 1560004

Xi'an, Shaanxi, China

Site Status

Investigational Site Number : 1560003

Jinan, Shandong, China

Site Status

Investigational Site Number : 1560008

Hangzhou, Zhejiang, China

Site Status

Investigational Site Number : 1560010

Wenzhou, Zhejiang, China

Site Status

Investigational Site Number : 1560007

Beijing, , China

Site Status

Investigational Site Number : 1560005

Beijing, , China

Site Status

Investigational Site Number : 1560006

Shanghai, , China

Site Status

Investigational Site Number : 1560002

Shenzhen, , China

Site Status

Investigational Site Number : 2500005

Brest, Finistère, France

Site Status

Investigational Site Number : 2500001

Nantes, , France

Site Status

Investigational Site Number : 3920001

Obihiro, Hokkaido, Japan

Site Status

Investigational Site Number : 3920003

Kyoto, , Japan

Site Status

Investigational Site Number : 3920004

Matsudo, , Japan

Site Status

Investigational Site Number : 5280001

Bergen op Zoom, North Brabant, Netherlands

Site Status

Investigational Site Number : 5280002

Hoofddorp, North Holland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada China France Japan Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1288-8567

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS17721

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Psoriatic Arthritis
NCT00001420 COMPLETED
Upadacitinib for Prurigo Nodularis
NCT06773403 RECRUITING PHASE4