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

NCT ID: NCT06087627

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2026-12-28

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.

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.

Conditions

Prurigo Nodularis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Dupilumab SAR231893 (REGN668)

Intervention Type: DRUG

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

Interventions

Dupilumab SAR231893 (REGN668)

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

Intervention Type: DRUG

Other Intervention Names

Dupixent®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number: 013

Adernach, , Germany

Site Status: RECRUITING

Investigational site number: 001

Berlin, , Germany

Site Status: RECRUITING

Investigational Site Number: 002

Berlin, , Germany

Site Status: RECRUITING

Investigational Site Number: 023

Chemnitz, , Germany

Site Status: RECRUITING

Investigational Site Number: 005

Düren, , Germany

Site Status: RECRUITING

Investigational Site Number: 004

Düsseldorf, , Germany

Site Status: RECRUITING

Investigational Site Number: 007

Hamburg, , Germany

Site Status: RECRUITING

Investigational Site Number: 016

Leipzig, , Germany

Site Status: RECRUITING

Investigational Site Number: 031

Mainz, , Germany

Site Status: RECRUITING

Investigational Site Number: 022

Potsdam, , Germany

Site Status: RECRUITING

Investigational Site Number: 024

Potsdam, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

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

Role: CONTACT

Contact-US@sanofi.com

800-633-1610 ext. option 6

Other Identifiers

U1111-1290-5823

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS17933

Identifier Type: -

Identifier Source: org_study_id