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

NCT05991323 | Active Not Recruiting

• 2 other identifiers: OBS17721U1111-1288-8567
• Study Type: observational
• Target: 100
• Locations: 6 countries
• Sites: 49

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 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.

Conditions

Prurigo Nodularis

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (26)

• Baseline Characteristics: PN-related medical history

  At baseline

• Baseline Characteristics: Socio-demographics of PN patients

  At baseline

• Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment

  At baseline

• Proportion of patients using concomitant medication

  At baseline

• Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)

  From baseline up to month 18

Study Arms (1)

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

Drug: Dupilumab

Interventions

Dupilumab DRUG

Injection solution; subcutaneous

Also known as: DUPIXENT, SAR231893

Patient with prurigo nodularis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants who initiate dupilumab treatment for prurigo nodularis (according to the country-specific prescribing information)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (49)

Medical Dermatology Specialists Site Number : 8400005

Phoenix, Arizona, 85006-2754, United States

Location

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

Phoenix, Arizona, 85008-3884, United States

Location

Center for Dermatology Clinical Research- Site Number : 8400002

Fremont, California, 94538, United States

Location

Halcyon Dermatology- Site Number : 8400023

Laguna Hills, California, 92653, United States

Location

Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015

Rancho Santa Margarita, California, 92688-3623, United States

Location

Golden State Dermatology- Site Number : 8400014

Walnut Creek, California, 94598-3335, United States

Location

Total Vein And Skin, LLC- Site Number : 8400019

Boynton Beach, Florida, 33437-3782, United States

Location

GSI Clinical Research- Site Number : 8400017

Margate, Florida, 33063-7011, United States

Location

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

Columbus, Georgia, 31904, United States

Location

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

Indianapolis, Indiana, 46250-2041, United States

Location

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

Auburn Hills, Michigan, 48326-3396, United States

Location

Derm Institute of Western Michigan- Site Number : 8400034

Caledonia, Michigan, 49316-7478, United States

Location

Dermatology Associates Western Michigan- Site Number : 8400033

Grand Rapids, Michigan, 49546-6204, United States

Location

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

Lee's Summit, Missouri, 64064, United States

Location

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

Omaha, Nebraska, 68105-1026, United States

Location

Vivida Dermatology - Flamingo- Site Number : 8400013

Las Vegas, Nevada, 89119, United States

Location

Las Vegas Dermatology- Site Number : 8400027

Las Vegas, Nevada, 89144-0518, United States

Location

Duke Dermatology Clinic- Site Number : 8400026

Durham, North Carolina, 27710-4000, United States

Location

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

Charleston, South Carolina, 29425-8903, United States

Location

North Texas Center for Clinical Research- Site Number : 8400012

Frisco, Texas, 75034, United States

Location

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

Longview, Texas, 75601, United States

Location

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

Lubbock, Texas, 79430-0002, United States

Location

West Virginia Research Institute- Site Number : 8400030

Morgantown, West Virginia, 26505-1873, United States

Location

Investigational Site Number : 1240009

Calgary, Alberta, T2J 7E1, Canada

Location

Investigational Site Number : 1240007

Edmonton, Alberta, T5K 2V4, Canada

Location

Investigational Site Number : 1240012

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigational Site Number : 1240006

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Investigational Site Number : 1240004

Ajax, Ontario, L1S 7K8, Canada

Location

Investigational Site Number : 1240003

Barrie, Ontario, L4M 7G1, Canada

Location

Investigational Site Number : 1240011

London, Ontario, N6H 5L5, Canada

Location

Investigational Site Number : 1240002

Newmarket, Ontario, L3Y 5G8, Canada

Location

Investigational Site Number : 1240005

Toronto, Ontario, M2M 4J5, Canada

Location

Investigational Site Number : 1240010

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigational Site Number : 1560009

Guangzhou, Guangdong, 510630, China

Location

Investigational Site Number : 1560004

Xi'an, Shaanxi, 710004, China

Location

Investigational Site Number : 1560003

Jinan, Shandong, 250001, China

Location

Investigational Site Number : 1560008

Hangzhou, Zhejiang, 311400, China

Location

Investigational Site Number : 1560010

Wenzhou, Zhejiang, 325000, China

Location

Investigational Site Number : 1560007

Beijing, 100050, China

Location

Investigational Site Number : 1560005

Beijing, 100083, China

Location

Investigational Site Number : 1560006

Shanghai, 200020, China

Location

Investigational Site Number : 1560002

Shenzhen, 518000, China

Location

Investigational Site Number : 2500005

Brest, Finistère, 29606, France

Location

Investigational Site Number : 2500001

Nantes, 44000, France

Location

Investigational Site Number : 3920001

Obihiro, Hokkaido, 080-0013, Japan

Location

Investigational Site Number : 3920003

Kyoto, 606-8507, Japan

Location

Investigational Site Number : 3920004

Matsudo, 271-0092, Japan

Location

Investigational Site Number : 5280001

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Investigational Site Number : 5280002

Hoofddorp, North Holland, 2134 TM, Netherlands

Location

MeSH Terms

Interventions

dupilumab

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 14, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (3); CA (10); CN (9); US (23); FR (2); NL (2)