Prurigo NodularisGLOBOSPINNCT05991323
Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
An observational study of Prurigo Nodularis, run by Sanofi at 49 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 12 Dec 2023to 8 Sep 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants who initiate dupilumab treatment for prurigo nodularis (according to the country-specific prescribing information)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States23 sites
Oakland Hills Dermatology - 3400 Auburn Rd- Site Number : 8400007
Auburn Hills, Michigan, 48326-3396
Total Vein And Skin, LLC- Site Number : 8400019
Boynton Beach, Florida, 33437-3782
Derm Institute of Western Michigan- Site Number : 8400034
Caledonia, Michigan, 49316-7478
Medical University of South Carolina (MUSC) - PPDS- Site Number : 8400001
Charleston, South Carolina, 29425-8903
Allergy Center at Brookstone Research - Centricity Research - PPDS- Site Number : 8400025
Columbus, Georgia, 31904
Duke Dermatology Clinic- Site Number : 8400026
Durham, North Carolina, 27710-4000
Center for Dermatology Clinical Research- Site Number : 8400002
Fremont, California, 94538
North Texas Center for Clinical Research- Site Number : 8400012
Frisco, Texas, 75034
Dermatology Associates Western Michigan- Site Number : 8400033
Grand Rapids, Michigan, 49546-6204
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave- Site Number : 8400003
Indianapolis, Indiana, 46250-2041
Halcyon Dermatology- Site Number : 8400023
Laguna Hills, California, 92653
Vivida Dermatology - Flamingo- Site Number : 8400013
Las Vegas, Nevada, 89119
Las Vegas Dermatology- Site Number : 8400027
Las Vegas, Nevada, 89144-0518
U.S. Dermatology Partners Lee's Summit- Site Number : 8400016
Lee's Summit, Missouri, 64064
U.S. Dermatology Partners Longview- Site Number : 8400032
Longview, Texas, 75601
Texas Tech University Health Sciences Center-125 W Hague Rd- Site Number : 8400010
Lubbock, Texas, 79430-0002
GSI Clinical Research- Site Number : 8400017
Margate, Florida, 33063-7011
West Virginia Research Institute- Site Number : 8400030
Morgantown, West Virginia, 26505-1873
University of Nebraska - Lauritzen Outpatient Center- Site Number : 8400029
Omaha, Nebraska, 68105-1026
Medical Dermatology Specialists Site Number : 8400005
Phoenix, Arizona, 85006-2754
Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024
Phoenix, Arizona, 85008-3884
Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015
Rancho Santa Margarita, California, 92688-3623
Golden State Dermatology- Site Number : 8400014
Walnut Creek, California, 94598-3335
Canada10 sites
Investigational Site Number : 1240004
Ajax, Ontario, L1S 7K8
Investigational Site Number : 1240003
Barrie, Ontario, L4M 7G1
Investigational Site Number : 1240009
Calgary, Alberta, T2J 7E1
Investigational Site Number : 1240007
Edmonton, Alberta, T5K 2V4
Investigational Site Number : 1240006
Fredericton, New Brunswick, E3B 1G9
Investigational Site Number : 1240011
London, Ontario, N6H 5L5
Investigational Site Number : 1240002
Newmarket, Ontario, L3Y 5G8
Investigational Site Number : 1240012
Surrey, British Columbia, V3R 6A7
Investigational Site Number : 1240005
Toronto, Ontario, M2M 4J5
Investigational Site Number : 1240010
Waterloo, Ontario, N2J 1C4
China9 sites
Investigational Site Number : 1560007
Beijing, 100050
Investigational Site Number : 1560005
Beijing, 100083
Investigational Site Number : 1560009
Guangzhou, Guangdong, 510630
Investigational Site Number : 1560008
Hangzhou, Zhejiang, 311400
Investigational Site Number : 1560003
Jinan, Shandong, 250001
Investigational Site Number : 1560006
Shanghai, 200020
Investigational Site Number : 1560002
Shenzhen, 518000
Investigational Site Number : 1560010
Wenzhou, Zhejiang, 325000
Investigational Site Number : 1560004
Xi'an, Shaanxi, 710004
Japan3 sites
Investigational Site Number : 3920003
Kyoto, 606-8507
Investigational Site Number : 3920004
Matsudo, 271-0092
Investigational Site Number : 3920001
Obihiro, Hokkaido, 080-0013
France2 sites
Investigational Site Number : 2500005
Brest, Finistère, 29606
Investigational Site Number : 2500001
Nantes, 44000
Netherlands2 sites
Investigational Site Number : 5280001
Bergen op Zoom, North Brabant, 4624 VT
Investigational Site Number : 5280002
Hoofddorp, North Holland, 2134 TM
About this study
Official title: 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.
Read the detailed description
The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.
- Conditions
- Prurigo Nodularis
- Being tested
- Dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called DUPIXENT, SAR231893
Injection solution; subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment
Measured: At baseline
Frequency of reasons for dupilumab treatment modifications with the description of the modified treatment
Measured: From baseline up to month 18
Proportion of patients who discontinued dupilumab
Measured: From baseline up to month 18
Frequency of reasons for dupilumab treatment discontinuation
Measured: From baseline up to month 18
Proportion of patients hospitalized due to PN
Measured: From baseline up to month 18
Secondary outcomes (26)
Baseline Characteristics: PN-related medical history
(e.g., date of diagnosis, severity, comorbidities)
Measured: 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)
Measured: At baseline
Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment
Measured: At baseline
Proportion of patients using concomitant medication
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to month 18
Percentage of patients experiencing AEs and SAEs
Measured: From baseline up to month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Dec 2023
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991323
- Sponsor's protocol ID
- OBS17721
- Other IDs
- U1111-1288-8567
- Acronym
- GLOBOSPIN
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT05991323
- Acronym / sponsor ID
- GLOBOSPIN / OBS17721
- Conditions
- Prurigo Nodularis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with prurigo nodularis | – | Drug: DupilumabParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants who initiate dupilumab treatment for prurigo nodularis (according to the country-specific prescribing information)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DUPIXENT, SAR231893Injection solution; subcutaneous | Drug | Patient with prurigo nodularis |
Primary outcome
Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment
Time frame: At baseline
Frequency of reasons for dupilumab treatment modifications with the description of the modified treatment
Time frame: From baseline up to month 18
Proportion of patients who discontinued dupilumab
Time frame: From baseline up to month 18
Frequency of reasons for dupilumab treatment discontinuation
Time frame: From baseline up to month 18
Proportion of patients hospitalized due to PN
Time frame: From baseline up to month 18
26 secondary outcomes
Baseline Characteristics: PN-related medical history
Time frame: At baseline
Baseline Characteristics: Socio-demographics of PN patients
Time frame: At baseline
Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment
Time frame: At baseline
Proportion of patients using concomitant medication
Time frame: At baseline
Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)
Time frame: From baseline up to month 18
Mean change in WI-NRS
Time frame: From baseline up to month 18
Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)
Time frame: From baseline up to month 18
Mean change in Skin Pain NRS
Time frame: From baseline up to month 18
Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)
Time frame: From baseline up to month 18
Mean change in Sleep Disturbance NRS
Time frame: 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)"
Time frame: From baseline up to month 18
Proportion of patients with PGIC score of "Very much better (improved)" or "Moderately better (improved)"
Time frame: From baseline up to month 18
Mean change in PGIC
Time frame: From baseline up to month 18
Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of "None"
Time frame: From baseline up to month 18
Proportion of patients with PGIS score of "None" or "Mild"
Time frame: From baseline up to month 18
Mean change in PGIS
Time frame: From baseline up to month 18
Mean change in Dermatology Life Quality Index (DLQI)
Time frame: From baseline up to month 18
Mean change in Pruritus Activity Score (PAS)
Time frame: 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
Time frame: From baseline up to month 18
Mean change in IGA-CPG Activity
Time frame: 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
Time frame: From baseline up to month 18
Mean change in IGA-CPG Stage
Time frame: From baseline up to month 18
Mean change in EQ-5D-5L
Time frame: From baseline up to month 18
Mean change in Hospital Anxiety and Depression Scale (HADS) total score
Time frame: 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
Time frame: From baseline up to month 18
Percentage of patients experiencing AEs and SAEs
Time frame: From baseline up to month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prurigo Nodularis, run by Sanofi at 49 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada, China, Japan, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.