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Prurigo NodularisCLEAR PNNCT06087627

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

An observational study of Prurigo Nodularis, run by Sanofi at 11 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. 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 SAR231893 (REGN668)
Type of treatment
Injection or infusion
How many people
110 participants
Where
11 sitesGermany
Study dates
27 Dec 2023to 31 Dec 2027
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Investigational Site Number: 013

    Adernach, 56626

  • Investigational site number: 001

    Berlin, 12203

  • Investigational Site Number: 002

    Berlin, 13507

  • Investigational Site Number: 023

    Chemnitz, 09117

  • Investigational Site Number: 005

    Düren, 52349

  • Investigational Site Number: 004

    Düsseldorf, 40219

  • Investigational Site Number: 007

    Hamburg, 22391

  • Investigational Site Number: 016

    Leipzig, 04371

  • Investigational Site Number: 031

    Mainz, 55128

  • Investigational Site Number: 022

    Potsdam, 14467

  • Investigational Site Number: 024

    Potsdam, 14469

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Dupilumab SAR231893 (REGN668)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893 (REGN668)Drug

    Also called Dupixent®

    Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)

Study groups in NCT06087627
Study groupRoleWhat they receive
PN treatmentParticipants ≥ 18 years suffering from moderate-to-severe PN who receive long-term dupilumab treatment for PN in a real-world setting in Germany.
Receives: Drug: Dupilumab SAR231893 (REGN668)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage (%) of participants with Investigator Global Assessment Prurigo Nodularis Stage (IGA-CPG-S) score 0 or 1 in 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).

    Measured: Month 6

  2. 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

    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.

    Measured: Baseline, Month 6

Secondary outcomes (38)

  1. Characterization of the participants who receive dupilumab for PN: Socio-demographic data

    Measured: Baseline

  2. Characterization of the participants who receive dupilumab for PN: Medical history of disease

    Measured: Baseline

  3. Characterization of the participants who receive dupilumab for PN: Previous PN treatment (including balneophototherapy and/or UV therapy)

    Measured: Baseline

  4. Characterization of the participants who receive dupilumab for PN: Current PN treatment (INN, topical and/or systemic)

    Measured: Baseline, Months 1, 3, 6, 9, 12, 18 and 24

  5. Characterization of the participants who receive dupilumab for PN: Concomitant medication (INN)

    Measured: Baseline, Months 1, 3, 6, 12 and 24

  6. Characterization of the participants who receive dupilumab for PN: Presence of relevant comorbidities or of other prurigo subtypes

    Relevant comorbidities include presence of associated atopic comorbidities or type 2 inflammatory diseases.

    Measured: Baseline

  7. Characterization of the participants who receive dupilumab for PN: Biomarker levels (if available)

    Measured: Baseline

  8. Characterization of the participants who receive dupilumab for PN: Laboratory results (if available)

    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.

    Measured: Baseline

  9. Characterization of the participants who receive dupilumab for PN: Reasons for initiation of dupilumab treatment

    Measured: Baseline

  10. 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

    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.

    Measured: Months 1, 3, 6, 12 and 24

  11. Effectiveness of dupilumab: Change in Prurigo Control Test (PCT) from baseline to month 6, month 12, and month 24 after initiation of dupilumab therapy

    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.

    Measured: Baseline to Months 6, 12 and 24

  12. 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

    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.

    Measured: Baseline to Months 3, 6, 9, 12, 18 and 24

  13. 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

    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.

    Measured: Baseline to Months 6, 9, 12, 18 and 24

  14. 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

    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.

    Measured: Baseline to Months 1, 3, 9, 12, 18 and 24

  15. 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

    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.

    Measured: Months 1, 3, 6, 9, 12, 18 and 24

  16. 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

    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.

    Measured: Months 1, 3, 9, 12, 18 and 24

  17. 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

    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.

    Measured: Months 6, 12 and 24

  18. 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

    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.

    Measured: Baseline to Months 6, 12 and 24

  19. 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

    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).

    Measured: Baseline to Months 3, 6, 12 and 24

  20. 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

    Measured: Baseline, Month 1, 3, 6, 12 and 24

  21. Effectiveness of dupilumab: Number and duration of hospitalization due to PN during the last 12 months after 12 and 24 months of dupilumab therapy

    Measured: Baseline to Month 12 and Month 24

  22. Pharmacodynamics of dupilumab: Pharmacodynamic response for selected biomarkers (total IgE, blood eosinophils) at month 12 and month 24 after initiation of dupilumab therapy

    Measured: Month 12, Month 24

  23. Treatment patterns during real-world use of dupilumab: Dupilumab dose regimens used over the study, and the duration with each regimen

    Measured: Baseline to Month 24

  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

    Measured: Baseline to Month 24

  25. 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

    Measured: Baseline to Month 24

  26. Treatment patterns during real-world use of dupilumab: Percentage of participants discontinuing dupilumab, including temporary or permanent discontinuation

    Measured: Baseline to Month 24

  27. Treatment patterns during real-world use of dupilumab: Type of treatment switched to after discontinuing dupilumab

    Measured: Baseline to Month 24

  28. Treatment patterns during real-world use of dupilumab: Duration of use, drug survival of dupilumab

    Measured: Baseline to Month 24

  29. Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment and longest gap length

    Measured: Baseline to Month 24

  30. Treatment patterns during real-world use of dupilumab: Concomitant therapies taken for PN

    Measured: Baseline to Month 24

  31. Treatment patterns during real-world use of dupilumab: Reason for switching or discontinuing dupilumab

    Measured: Baseline to Month 24

  32. Treatment patterns during real-world use of dupilumab: Time from baseline to self-administer dupilumab at home

    Measured: Baseline to Month 24

  33. Safety: Occurrence and type of Treatment-Emergent Adverse Events (TEAEs) during the observational period

    Measured: Baseline to Month 24

  34. Safety: Occurrence and type of dupilumab-related TEAEs during the observational period

    Measured: Baseline to Month 24

  35. Safety: Event rate (per patient year) by type of TEAEs during the observational period

    Measured: Baseline to Month 24

  36. Safety: Event rate (per patient year) by type of dupilumab-related TEAEs during the observational period

    Measured: Baseline to Month 24

  37. Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment

    Measured: Baseline to Month 24

  38. Treatment patterns during real-world use of dupilumab: Longest gap length in dupilumab treatment

    Measured: Baseline to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start27 Dec 2023
  3. Primary completion29 Jun 2026
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
110 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087627
Sponsor's protocol ID
OBS17933
Other IDs
U1111-1290-5823
Acronym
CLEAR PN
Status last verified
Jul 2026
First submitted
29 Sep 2023
Last updated
31 Jul 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

Questions about this trial

What is this clinical trial studying?

An observational study of Prurigo Nodularis, run by Sanofi at 11 sites in Germany.

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 5 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. 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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage (%) of participants with Investigator Global Assessment Prurigo Nodularis Stage (IGA-CPG-S) score 0 or 1 in Month 6 (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06087627.

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 31 Jul 2026.

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