Study to Describe Dupilumab Long-term Treatment, Safety, and Patient Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Practice

What this Trial Is About

Prurigo nodularis (PN) is a skin condition marked by intensely itching nodules that cause uncontrollable scratching and skin injuries. Researchers are studying the long-term use of dupilumab (Dupixent®) in adults aged 18 and older with moderate-to-severe PN in a real-world setting in Germany. The study aims to describe the effectiveness and safety of dupilumab treatment and understand patient-reported outcomes over time. Participants in this non-interventional study receive dupilumab as prescribed by their treating physician according to standard medical practice. The study observes patients who start dupilumab treatment either at the beginning of the study or within the previous 7 days. The observational period lasts up to 2 years, with assessments at baseline, 1 month after starting treatment, and then every 3 months during the first year, followed by every 6 months during the second year. During the study, participants will have various evaluations, including medical history, current and previous treatments, biomarker and laboratory tests if available, and several patient-reported questionnaires on disease control, quality of life, itch severity, sleep, and psychological well-being. Researchers will monitor treatment patterns, dosing changes, discontinuations, adverse events, and the overall long-term safety and effectiveness of dupilumab. The main outcomes include improvements in disease severity and itch reduction at 6 months, with ongoing assessments throughout the study period.

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