A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine (CLEAR PN)

July 29, 2026 updated by: Sanofi

Prospective, Non-interventional Observational Study to Characterize Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine

Prurigo nodularis (PN) is a skin disease characterized by the presence of single to multiple symmetrically distributed, intensively itching nodules. The main symptom is uncontrollable itching leading to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes injuries to the skin. In recent years, number of studies evaluating PN, the affected population and the disease burden has increased but PN remains still understudied. This non-interventional study is intended to describe the long-term effectiveness of dupilumab (Dupixent®) in participants aged 18 years or older and suffering from moderate-to-severe PN who receive dupilumab for PN treatment in a real-world setting in Germany according to the prescribing information (Summary of Product Characteristics [SmPC]). The decision to initiate dupilumab treatment is made by the treating physician and participant according to the participant's medical need and to the standard of best medical practice. This decision is made independently and before data inclusion in this non-interventional study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The individual observational period is planned to be up to 2 years, with assessments at baseline, one month after baseline and afterwards, every 3 months in the 1st and every 6 months in the 2nd year after dupilumab initiation, respectively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Germany
      • Adernach, Germany, 56626
        • Investigational Site Number: 013
      • Berlin, Germany, 12203
        • Investigational Site Number: 001
      • Berlin, Germany, 13507
        • Investigational Site Number: 002
      • Chemnitz, Germany, 09117
        • Investigational Site Number: 023
      • Düren, Germany, 52349
        • Investigational Site Number: 005
      • Düsseldorf, Germany, 40219
        • Investigational Site Number: 004
      • Hamburg, Germany, 22391
        • Investigational Site Number: 007
      • Leipzig, Germany, 04371
        • Investigational Site Number: 016
      • Mainz, Germany, 55128
        • Investigational Site Number: 031
      • Potsdam, Germany, 14467
        • Investigational Site Number: 022
      • Potsdam, Germany, 14469
        • Investigational Site Number: 024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants ≥ 18 years suffering from moderate-to-severe PN who receive long-term dupilumab treatment for PN in a real-world setting in Germany.

Description

Inclusion Criteria:

  • Participants at least 18 years of age at baseline visit
  • Signed written informed consent
  • New initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the prescribing information/Summary of Product Characteristics (SmPC)
  • Patients who received the initial diagnosis of PN

Exclusion Criteria:

  • Patients who have a contraindication to dupilumab according to the current prescribing information label/SmPC
  • Patients who have been treated for more than 7 days with dupilumab
  • Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results
  • Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PN treatment
Participants ≥ 18 years suffering from moderate-to-severe PN who receive long-term dupilumab treatment for PN in a real-world setting in Germany.
Drug: Dupilumab SAR231893 (REGN668)
Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)
Other Names:
  • Dupixent®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage (%) of participants with Investigator Global Assessment Prurigo Nodularis Stage (IGA-CPG-S) score 0 or 1 in Month 6
Time Frame: Month 6
IGA CPG-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis (PN).
Month 6
Percentage (%) of participants with greater than or equal to (≥) 4-point improvement (reduction) in Worst Itch Numerical Rating Scale (WI-NRS) from baseline to Month 6
Time Frame: Baseline, Month 6
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Baseline, Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characterization of the participants who receive dupilumab for PN: Socio-demographic data
Time Frame: Baseline
Baseline
Characterization of the participants who receive dupilumab for PN: Medical history of disease
Time Frame: Baseline
Baseline
Characterization of the participants who receive dupilumab for PN: Previous PN treatment (including balneophototherapy and/or UV therapy)
Time Frame: Baseline
Baseline
Characterization of the participants who receive dupilumab for PN: Current PN treatment (INN, topical and/or systemic)
Time Frame: Baseline, Months 1, 3, 6, 9, 12, 18 and 24
Baseline, Months 1, 3, 6, 9, 12, 18 and 24
Characterization of the participants who receive dupilumab for PN: Concomitant medication (INN)
Time Frame: Baseline, Months 1, 3, 6, 12 and 24
Baseline, Months 1, 3, 6, 12 and 24
Characterization of the participants who receive dupilumab for PN: Presence of relevant comorbidities or of other prurigo subtypes
Time Frame: Baseline
Relevant comorbidities include presence of associated atopic comorbidities or type 2 inflammatory diseases.
Baseline
Characterization of the participants who receive dupilumab for PN: Biomarker levels (if available)
Time Frame: Baseline
Baseline
Characterization of the participants who receive dupilumab for PN: Laboratory results (if available)
Time Frame: Baseline
Data for any of the following laboratory parameters will be collected as available in routine clinical practice and expressed in the units relevant for the respective parameter: bilirubin, aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (gamma GT), alkaline phosphatase, differential blood count, ferritin, erythrocyte sedimentation rate, C-reactive protein.
Baseline
Characterization of the participants who receive dupilumab for PN: Reasons for initiation of dupilumab treatment
Time Frame: Baseline
Baseline
Effectiveness of dupilumab: Patient Global Impression of Change (PGIC) of PN disease at month 1, month 3, month 6, month 12, and month 24 of dupilumab therapy
Time Frame: Months 1, 3, 6, 12 and 24
PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Patients are asked to rate their overall status since the start of the study from "very much improved" to "very much worse". Scores range from 1 to 7, with higher score indicating worse health status.
Months 1, 3, 6, 12 and 24
Effectiveness of dupilumab: Change in Prurigo Control Test (PCT) from baseline to month 6, month 12, and month 24 after initiation of dupilumab therapy
Time Frame: Baseline to Months 6, 12 and 24
PCT is a self-administered, simple 5-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 5 questions are summed up. Accordingly, the minimum and maximum PCT scores are 0 and 20, with higher scores indicating a higher level of disease control.
Baseline to Months 6, 12 and 24
Effectiveness of dupilumab: Change in Dermatology Life Quality Index (DLQI) from baseline to month 3, month 6, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy
Time Frame: Baseline to Months 3, 6, 9, 12, 18 and 24
DLQI is developed to measure dermatology specific Health-Related Quality of Life (HRQoL) in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Baseline to Months 3, 6, 9, 12, 18 and 24
Effectiveness of dupilumab: Change in Sleep Numerical Rating Scale (Sleep-NRS) from baseline to month 6, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy
Time Frame: Baseline to Months 6, 9, 12, 18 and 24
Sleep-NRS was used to measure sleep intensity. Participants were asked to rate their sleep quality on their past night upon awakening, using a 11-point NRS ranging from 0 to 10, where 0 = worst possible sleep and 10 = best possible sleep. Higher scores indicated less severity.
Baseline to Months 6, 9, 12, 18 and 24
Effectiveness of dupilumab: Percentage (%) of participants with ≥ 4-point improvement (reduction) in WI-NRS from baseline to month 1, month 3, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy
Time Frame: Baseline to Months 1, 3, 9, 12, 18 and 24
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Baseline to Months 1, 3, 9, 12, 18 and 24
Effectiveness of dupilumab: Percentage (%) of participants with IGA-CPG activity (IGA-CPG-A) score of 0 or 1 at month 1, month 3, month 6, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy
Time Frame: Months 1, 3, 6, 9, 12, 18 and 24
The IGA CPG-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear (0% nodules showing excoriations/crusts), 1 = almost clear (up to 10% nodules showing excoriations/crusts), 2 = mild (11-25% nodules showing excoriations/crusts), 3 = moderate (26-75% nodules showing excoriations/crusts) and 4 = severe (76-100% of nodules showing excoriations/crusts). Higher scores indicate severe PN.
Months 1, 3, 6, 9, 12, 18 and 24
Effectiveness of dupilumab: Percentage (%) of participants with IGA-CPG-S score of 0 or 1 in month 1, month 3, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy
Time Frame: Months 1, 3, 9, 12, 18 and 24
IGA CPG-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN.
Months 1, 3, 9, 12, 18 and 24
Effectiveness of dupilumab: Percentage (%) of participants with Patient Benefit Index-Pruritus (PBI-P) ≥ 1 at month 6, month 12, and month 24 of dupilumab therapy
Time Frame: Months 6, 12 and 24
PBI-P is a validated questionnaire where, prior to treatment, individual participants determine how different benefits of therapy would be relevant for them. After treatment, participants will be asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value is calculated, which represents the patient relevant therapy benefits. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for 'does/did not apply to me' = 5; and missing value = -9. Higher scores indicate better outcome.
Months 6, 12 and 24
Effectiveness of dupilumab: Change in Hospital Depression and Anxiety Score (HADS total score) from baseline to month 6, month 12, and month 24 of dupilumab therapy
Time Frame: Baseline to Months 6, 12 and 24
HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale comprised of 7 items with a scoring range from 0 (less severity of anxiety and depression) to 21 (greater severity of anxiety and depression symptoms) for each subscale. The total HADS score ranges from 0 (less severity) to 42 (more severity), with a high score indicative of severe anxiety and/or depression level.
Baseline to Months 6, 12 and 24
Effectiveness of dupilumab: Percentage of participants who achieve ≥ 75% healed lesions from Prurigo Activity Score (PAS) from baseline to month 3, month 6, month 12, and month 24 of dupilumab therapy
Time Frame: Baseline to Months 3, 6, 12 and 24
The items of the PAS evaluate the type (visible lesions: item 1a; predominant lesions: item1b), estimated number (item 2), distribution (item 3, 4) and size (biggest lesion: item 6a; representative lesion: item 6b) of pruriginous lesions, the representative body area and exact number of lesions (item 5), the activity in terms of percentage of pruriginous lesions with excoriations/crusts on top (reflecting active scratching; item 7a) and the percentage of healed pruriginous lesions (reflecting healing of CPG; item 7b).
Baseline to Months 3, 6, 12 and 24
Effectiveness of dupilumab: Number of sick-leave days at work due to PN during the last 12 months before baseline and since the last visit after starting dupilumab treatment
Time Frame: Baseline, Month 1, 3, 6, 12 and 24
Baseline, Month 1, 3, 6, 12 and 24
Effectiveness of dupilumab: Number and duration of hospitalization due to PN during the last 12 months after 12 and 24 months of dupilumab therapy
Time Frame: Baseline to Month 12 and Month 24
Baseline to Month 12 and Month 24
Pharmacodynamics of dupilumab: Pharmacodynamic response for selected biomarkers (total IgE, blood eosinophils) at month 12 and month 24 after initiation of dupilumab therapy
Time Frame: Month 12, Month 24
Month 12, Month 24
Treatment patterns during real-world use of dupilumab: Dupilumab dose regimens used over the study, and the duration with each regimen
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Percentage of participants whose dose (either the frequency or the strength) increased from starting regimen and reasons
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Percentage of participants whose dose (either the frequency or the strength) decreased from the starting regimen and reasons
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Percentage of participants discontinuing dupilumab, including temporary or permanent discontinuation
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Type of treatment switched to after discontinuing dupilumab
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Duration of use, drug survival of dupilumab
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Longest gap length in dupilumab treatment
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Concomitant therapies taken for PN
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Reason for switching or discontinuing dupilumab
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Time from baseline to self-administer dupilumab at home
Time Frame: Baseline to Month 24
Baseline to Month 24
Safety: Occurrence and type of Treatment-Emergent Adverse Events (TEAEs) during the observational period
Time Frame: Baseline to Month 24
Baseline to Month 24
Safety: Occurrence and type of dupilumab-related TEAEs during the observational period
Time Frame: Baseline to Month 24
Baseline to Month 24
Safety: Event rate (per patient year) by type of TEAEs during the observational period
Time Frame: Baseline to Month 24
Baseline to Month 24
Safety: Event rate (per patient year) by type of dupilumab-related TEAEs during the observational period
Time Frame: Baseline to Month 24
Baseline to Month 24
Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment and longest gap length
Time Frame: Baseline to Month 24
Baseline to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OBS17933
  • U1111-1290-5823 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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