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

Launched by SANOFI · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects and safety of a medication called dupilumab (brand name Dupixent®) for people suffering from a skin condition known as prurigo nodularis, which causes severe itching and skin nodules. The trial aims to gather information about how well dupilumab works for patients in real-life situations, specifically those aged 18 and older who have just started or recently begun treatment with this medication.

To participate in this study, individuals must be at least 18 years old and have received a diagnosis of moderate to severe prurigo nodularis. They should also be starting dupilumab treatment or have begun it within the last week. However, those who have certain health issues that prevent them from taking dupilumab or have been on the medication for more than a week cannot join. Participants will be asked to provide feedback about their experiences during the study, helping researchers understand how effective and safe the treatment is over time. If you're considering joining, it's important to discuss it with your doctor to see if it’s a good fit for you.

Gender

ALL

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.