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NCT06087627 · ClinicalTrials.gov record · last posted 2026-07-31

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

Study acronym: CLEAR PN
StatusActive, Not Recruiting
PhaseNot specified
SponsorSanofi
Started2023-12-27
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-01
notable
Enrollment closed, study ongoing
2026-08-01
notable
Enrollment reduced: 150 → 110 participants
2026-08-01
minor
Completion pushed: 2026-12-28 → 2027-12-31
Trial Details
NCT Number NCT06087627
Lead Sponsor Sanofi
Conditions Prurigo Nodularis
Enrollment 110 participants
Start Date 2023-12-27
Primary Completion 2026-06-29 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-31