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

NCT06087627 | Recruiting

• 2 other identifiers: OBS17933U1111-1290-5823
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Prurigo Nodularis

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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 Outcomes (38)

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

  Baseline

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

  Baseline

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

  Baseline

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

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

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

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

Study Arms (1)

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)

Interventions

Dupilumab SAR231893 (REGN668) DRUG

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

Also known as: Dupixent®

PN treatment

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

Investigational Site Number: 013

Adernach, 56626, Germany

RECRUITING

Investigational site number: 001

Berlin, 12203, Germany

RECRUITING

Investigational Site Number: 002

Berlin, 13507, Germany

RECRUITING

Investigational Site Number: 023

Chemnitz, 09117, Germany

RECRUITING

Investigational Site Number: 005

Düren, 52349, Germany

RECRUITING

Investigational Site Number: 004

Düsseldorf, 40219, Germany

RECRUITING

Investigational Site Number: 007

Hamburg, 22391, Germany

RECRUITING

Investigational Site Number: 016

Leipzig, 04371, Germany

RECRUITING

Investigational Site Number: 031

Mainz, 55128, Germany

RECRUITING

Investigational Site Number: 022

Potsdam, 14467, Germany

RECRUITING

Investigational Site Number: 024

Potsdam, 14469, Germany

RECRUITING

MeSH Terms

Interventions

dupilumab

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 18, 2023
• Study Start: December 27, 2023
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (11)