Re-UNITE PN

Real-world Experience on Using Nemolizumab in the Treatment of Moderate-severe Adult Prurigo Nodularis in Audlts

Study Description

This prospective, multicenter, non-interventional study (NIS) seeks to evaluate PN treatment with nemolizumab (Nemluvio®) in adults over an approximately 12 month period using physician assessments in routine clinical practice and PRO measures. Treatment with nemolizumab will be determined solely by the participant’s physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice.

Brief Summary

The main aim of this study is to assess real-world effectiveness of nemolizumab in Prurigo nodularis (PN) as measured by investigator and patient reported outcome (PRO) in clinical practice at Month 6.

Condition or Disease

Prurigo Nodularis

Study Design

Study Type:	Observational
Estimated Enrollment:	600
Primary Outcome Measures	1. Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6 2. Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6
Actual Study Start Date:	August 2025
Estimated Primary Completion Date:	November 2027

Eligibility Criteria

Ages Eligible for Study:	18 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Prurigo Nodularis

Inclusion Criteria

Participants who, according to the treating physician’s decision and in line with the local package label, are newly initiated on nemolizumab (Nemluvio®) for the treatment of PN
Participants greater than or equal to (>=) 18 years of age
Participants who signed the written informed consent form (ICF)

Exclusion Criteria

Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label
Participants who received treatment with a drug under clinical development/ investigation within 3 months prior to baseline
Participants who received nemolizumab previously
Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires

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