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

Last updated: April 1, 2025
Sponsor: Sanofi
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Warts

Prurigo Nodularis

Treatment

Dupilumab

Clinical Study ID

NCT05991323
OBS17721
U1111-1288-8567
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 andindependently 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 beforeinclusion in the study.

Exclusion

Exclusion Criteria:

  • Patients who have a contraindication to dupilumab according to the country-specificprescribing information label.

  • Any condition that, in the opinion of the Investigator, may interfere with thepatient's ability to participate in the study, such as short life expectancy,substance abuse, severe cognitive impairment, or other comorbidities that canpredictably prevent the patient from completing the schedule of visits andassessments.

  • Patients currently participating in any interventional clinical trial.

  • Prior use of dupilumab within 6 months of the screening visit, or within 6 months ofthe baseline visit if screening and baseline occur on the same day.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase:
Study Start date:
December 12, 2023
Estimated Completion Date:
June 29, 2029

Study Description

The follow-up period will be 36 months or until death, loss to follow-up, or withdrawal, whichever comes first.

Connect with a study center

  • Investigational Site Number : 1240009

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Investigational Site Number : 1240007

    Edmonton, Alberta T5K 2V4
    Canada

    Site Not Available

  • Investigational Site Number : 1240012

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Investigational Site Number : 1240006

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigational Site Number : 1240004

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Investigational Site Number : 1240003

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Investigational Site Number : 1240011

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Investigational Site Number : 1240002

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Investigational Site Number : 1240001

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Investigational Site Number : 1240004

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240005

    Toronto, Ontario M2M 4J5
    Canada

    Site Not Available

  • Investigational Site Number : 1240010

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Investigational Site Number : 1560009

    Guangzhou, Guangdong 510630
    China

    Site Not Available

  • Investigational Site Number : 1560004

    Xi'an, Shaanxi 710004
    China

    Site Not Available

  • Investigational Site Number : 1560003

    Jinan, Shandong 250001
    China

    Site Not Available

  • Investigational Site Number : 1560008

    Hangzhou, Zhejiang 311400
    China

    Site Not Available

  • Investigational Site Number : 1560010

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Investigational Site Number : 1560005

    Beijing, 100083
    China

    Site Not Available

  • Investigational Site Number : 1560007

    Beijing, 100050
    China

    Site Not Available

  • Investigational Site Number : 1560006

    Shanghai, 200020
    China

    Site Not Available

  • Investigational Site Number : 1560002

    Shenzhen, 518000
    China

    Site Not Available

  • Investigational Site Number : 1560004

    Xian, 710004
    China

    Site Not Available

  • Investigational Site Number : 2500005

    Brest, Finistère 29606
    France

    Site Not Available

  • Investigational Site Number : 2500001

    Nantes, 44000
    France

    Site Not Available

  • Investigational Site Number : 3920001

    Obihiro, Hokkaido 080-0013
    Japan

    Site Not Available

  • Investigational Site Number : 3920003

    Kyoto, 606-8507
    Japan

    Site Not Available

  • Investigational Site Number : 3920004

    Matsudo, 271-0092
    Japan

    Site Not Available

  • Investigational Site Number : 5280001

    Bergen Op Zoom, Noord-Brabant 4624 VT
    Netherlands

    Site Not Available

  • Investigational Site Number : 5280002

    Hoofddorp, Noord-Holland 2134 TM
    Netherlands

    Site Not Available

  • Medical Dermatology Specialists Site Number : 8400005

    Phoenix, Arizona 85006-2754
    United States

    Site Not Available

  • Medical Dermatology Specialists- Site Number : 8400005

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

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

    Phoenix, Arizona 85008-3884
    United States

    Site Not Available

  • Southwest Skin Specialists, 4400 N 32nd St- Site Number : 8400028

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

  • Integrated Dermatology of Yuma- Site Number : 8400018

    Yuma, Arizona 85364-7132
    United States

    Site Not Available

  • First OC Dermatology - Fountain Valley- Site Number : 8400035

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • Center for Dermatology Clinical Research- Site Number : 8400002

    Fremont, California 94538
    United States

    Site Not Available

  • Halcyon Dermatology- Site Number : 8400023

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015

    Rancho Santa Margarita, California 92688-3623
    United States

    Site Not Available

  • Golden State Dermatology- Site Number : 8400014

    Walnut Creek, California 94598-3335
    United States

    Site Not Available

  • Total Vein And Skin, LLC- Site Number : 8400019

    Boynton Beach, Florida 33437-3782
    United States

    Site Not Available

  • Palm Beach Dermatology Group- Site Number : 8400020

    Delray Beach, Florida 33484-6500
    United States

    Site Not Available

  • GSI Clinical Research- Site Number : 8400017

    Margate, Florida 33063-7011
    United States

    Site Not Available

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

    Columbus, Georgia 31904
    United States

    Site Not Available

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

    Indianapolis, Indiana 46250-2041
    United States

    Site Not Available

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

    Auburn Hills, Michigan 48326-3396
    United States

    Site Not Available

  • Derm Institute of Western Michigan- Site Number : 8400034

    Caledonia, Michigan 49316-7478
    United States

    Site Not Available

  • Dermatology Associates Western Michigan- Site Number : 8400033

    Grand Rapids, Michigan 49546-6204
    United States

    Site Not Available

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

    Lee's Summit, Missouri 64064
    United States

    Site Not Available

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

    Omaha, Nebraska 68105-1026
    United States

    Site Not Available

  • Las Vegas Dermatology- Site Number : 8400027

    Las Vegas, Nevada 89144-0518
    United States

    Site Not Available

  • Las Vegas Dermatology_Investigational Site Number: 8400027

    Las Vegas, Nevada 89144-0518
    United States

    Active - Recruiting

  • Vivida Dermatology - Flamingo Rd - Probity - PPDS- Site Number : 8400013

    Las Vegas, Nevada 89119-5190
    United States

    Active - Recruiting

  • Vivida Dermatology - Flamingo- Site Number : 8400013

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Duke Dermatology Clinic- Site Number : 8400026

    Durham, North Carolina 27710-4000
    United States

    Site Not Available

  • Apex Dermatology and Skin Surgery Center- Site Number : 8400006

    Painesville, Ohio 44077-9618
    United States

    Site Not Available

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

    Charleston, South Carolina 29425-8903
    United States

    Site Not Available

  • North Texas Center for Clinical Research Site Number : 8400012

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • North Texas Center for Clinical Research- Site Number : 8400012

    Frisco, Texas 75034
    United States

    Site Not Available

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

    Longview, Texas 75601
    United States

    Site Not Available

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

    Lubbock, Texas 79430-0002
    United States

    Site Not Available

  • West Virginia Research Institute- Site Number : 8400030

    Morgantown, West Virginia 26505-1873
    United States

    Site Not Available

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