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

A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: Dupilumab

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Investigational Site Number : 1240009
    • Edmonton, Alberta, Canada, T5K 2V4
      • Investigational Site Number : 1240007
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Investigational Site Number : 1240012
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Investigational Site Number : 1240006
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • Investigational Site Number : 1240004
    • Barrie, Ontario, Canada, L4M 7G1
      • Investigational Site Number : 1240003
    • London, Ontario, Canada, N6H 5L5
      • Investigational Site Number : 1240011
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Investigational Site Number : 1240002
    • Toronto, Ontario, Canada, M2M 4J5
      • Investigational Site Number : 1240005
    • Waterloo, Ontario, Canada, N2J 1C4
      • Investigational Site Number : 1240010
• China
  • Beijing, China, 100050
    • Investigational Site Number : 1560007
  • Beijing, China, 100083
    • Investigational Site Number : 1560005
  • Shanghai, China, 200020
    • Investigational Site Number : 1560006
  • Shenzhen, China, 518000
    • Investigational Site Number : 1560002
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Investigational Site Number : 1560009
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Investigational Site Number : 1560004
  • Shandong
    • Jinan, Shandong, China, 250001
      • Investigational Site Number : 1560003
  • Zhejiang
    • Hangzhou, Zhejiang, China, 311400
      • Investigational Site Number : 1560008
    • Wenzhou, Zhejiang, China, 325000
      • Investigational Site Number : 1560010
• France
  • Nantes, France, 44000
    • Investigational Site Number : 2500001
  • Finistère
    • Brest, Finistère, France, 29606
      • Investigational Site Number : 2500005
• Japan
  • Kyoto, Japan, 606-8507
    • Investigational Site Number : 3920003
  • Matsudo, Japan, 271-0092
    • Investigational Site Number : 3920004
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0013
      • Investigational Site Number : 3920001
• Netherlands
  • North Brabant
    • Bergen op Zoom, North Brabant, Netherlands, 4624 VT
      • Investigational Site Number : 5280001
  • North Holland
    • Hoofddorp, North Holland, Netherlands, 2134 TM
      • Investigational Site Number : 5280002
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006-2754
      • Medical Dermatology Specialists Site Number : 8400005
    • Phoenix, Arizona, United States, 85008-3884
      • Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research- Site Number : 8400002
    • Laguna Hills, California, United States, 92653
      • Halcyon Dermatology- Site Number : 8400023
    • Rancho Santa Margarita, California, United States, 92688-3623
      • Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015
    • Walnut Creek, California, United States, 94598-3335
      • Golden State Dermatology- Site Number : 8400014
  • Florida
    • Boynton Beach, Florida, United States, 33437-3782
      • Total Vein And Skin, LLC- Site Number : 8400019
    • Margate, Florida, United States, 33063-7011
      • GSI Clinical Research- Site Number : 8400017
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Allergy Center at Brookstone Research - Centricity Research - PPDS- Site Number : 8400025
  • Indiana
    • Indianapolis, Indiana, United States, 46250-2041
      • Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave- Site Number : 8400003
  • Michigan
    • Auburn Hills, Michigan, United States, 48326-3396
      • Oakland Hills Dermatology - 3400 Auburn Rd- Site Number : 8400007
    • Caledonia, Michigan, United States, 49316-7478
      • Derm Institute of Western Michigan- Site Number : 8400034
    • Grand Rapids, Michigan, United States, 49546-6204
      • Dermatology Associates Western Michigan- Site Number : 8400033
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • U.S. Dermatology Partners Lee's Summit- Site Number : 8400016
  • Nebraska
    • Omaha, Nebraska, United States, 68105-1026
      • University of Nebraska - Lauritzen Outpatient Center- Site Number : 8400029
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vivida Dermatology - Flamingo- Site Number : 8400013
    • Las Vegas, Nevada, United States, 89144-0518
      • Las Vegas Dermatology- Site Number : 8400027
  • North Carolina
    • Durham, North Carolina, United States, 27710-4000
      • Duke Dermatology Clinic- Site Number : 8400026
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8903
      • Medical University of South Carolina (MUSC) - PPDS- Site Number : 8400001
  • Texas
    • Frisco, Texas, United States, 75034
      • North Texas Center for Clinical Research- Site Number : 8400012
    • Longview, Texas, United States, 75601
      • U.S. Dermatology Partners Longview- Site Number : 8400032
    • Lubbock, Texas, United States, 79430-0002
      • Texas Tech University Health Sciences Center-125 W Hague Rd- Site Number : 8400010
  • West Virginia
    • Morgantown, West Virginia, United States, 26505-1873
      • West Virginia Research Institute- Site Number : 8400030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Injection solution; subcutaneous; Other Names: SAR231893; DUPIXENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Characteristics: PN-related medical history	(e.g., date of diagnosis, severity, comorbidities)	At baseline
Baseline Characteristics: Socio-demographics of PN patients	(e.g., month and year of birth (where allowed) or age, gender, race (if allowed), ethnicity (if allowed), Fitzpatrick skin type)	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)	The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.	From baseline up to month 18
Mean change in WI-NRS	The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.	From baseline up to month 18
Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)	The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 ("No pain") to 10 ("Worst pain imaginable"). Scores range from 0 to10, with higher scores indicating greater pain intensity.	From baseline up to month 18
Mean change in Skin Pain NRS	The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 ("No pain") to 10 ("Worst pain imaginable"). Scores range from 0 to10, with higher scores indicating greater pain intensity.	From baseline up to month 18
Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)	The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.	From baseline up to month 18
Mean change in Sleep Disturbance NRS	The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.	From baseline up to month 18
Proportion of patients with Patient Global Impression of Change of PN Disease (PGIC) score of "Very much better (improved)"	The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.	From baseline up to month 18
Proportion of patients with PGIC score of "Very much better (improved)" or "Moderately better (improved)"	The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.	From baseline up to month 18
Mean change in PGIC	The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.	From baseline up to month 18
Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of "None"	The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.	From baseline up to month 18
Proportion of patients with PGIS score of "None" or "Mild"	The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.	From baseline up to month 18
Mean change in PGIS	The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.	From baseline up to month 18
Mean change in Dermatology Life Quality Index (DLQI)	The DLQI is designed to measure the health-related quality of life of adults with a skin disease. The DLQI consists of 10 questions related to the effect of skin disease over the past week. Overall scoring ranges from 0 to 30, with a high score indicative of a poorer Health-Related Quality of Life (HRQoL)	From baseline up to month 18
Mean change in Pruritus Activity Score (PAS)	The modified PAS is a clinical-reported measure that evaluates the pruritic lesions. The modified questionnaire consists of five items: the type (visible lesions: item 1a; predominant lesions: item1b), estimated number (item 2), distribution (item 3), the representative body area and exact number of lesions (item 4), and the activity in terms of percentage of pruriginous lesions with excoriations/crusts on top (reflecting active scratching; item 5a) and the percentage of healed pruriginous lesions (reflecting healing of chronic prurigo; item 5b). The modified PAS will be completed based on the standard of care clinical assessment.	From baseline up to month 18
Proportion of patients with Investigator's Global Assessment-chronic prurigo Activity (IGA-CPG Activity) score of 0 or 1	The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.	From baseline up to month 18
Mean change in IGA-CPG Activity	The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.	From baseline up to month 18
Proportion of patients with Investigator's Global Assessment-chronic prurigo Stage (IGA-CPG Stage) score of 0 or 1	The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.	From baseline up to month 18
Mean change in IGA-CPG Stage	The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.	From baseline up to month 18
Mean change in EQ-5D-5L	The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	From baseline up to month 18
Mean change in Hospital Anxiety and Depression Scale (HADS) total score	The HADS is a Patient-Reported Outcomes (PRO) instrument for screening anxiety and depression in non-psychiatric populations. The HADS consists of 14 items, 7 each for anxiety and depression symptoms. Patients select a response from 0 to 3 for each item, based on how they have been feeling in the past week. Scores range from 0 to 21 for each subscale. HADS anxiety (HADS-A) and HADS depression (HADS-D) scores ≤ 7 indicate no clinically relevant symptoms (normal), 8 to 10 borderline abnormal (borderline case), and 11 to 21 abnormal (maximum 21) indicating more severe symptoms.	From baseline up to month 18
Proportion of patients reported working, absenteeism score, presenteeism score, and overall impairment working score using the Work Productivity and Activity Impairment (WPAI) questionnaire	The Work Productivity and Activity Impairment General Health (WPAI-GH) is a 6-item Patient-Reported Outcomes (PRO) instrument that measures the effect of a condition on productivity during work and regular activities in the seven days prior to completion. The instrument comprises 4 domains: absenteeism, presenteeism, overall work impairment, and activity impairment due to health. WPAI-GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.	From baseline up to month 18
Percentage of patients experiencing AEs and SAEs		From baseline up to month 18

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis; dupilumab
• Other Study ID Numbers: OBS17721; U1111-1288-8567 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No