Atopic Dermatitis Clinical Study (12 yrs+)

Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults

Study Description

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. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine.

Brief Summary

The main aim of the study is to assess real-world effectiveness of nemolizumab in Atopic Dermatitis (AD) as measured by physician assessment and patient reported outcome (PRO) in clinical practice at Month 6.

Condition or Disease

Atopic Dermatitis

Study Design

Study Type:	Observational
Estimated Enrollment:	1,000
Primary Outcome Measures	1. Investigator Global Assessment (IGA) at Month 6 2. Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6
Actual Study Start Date:	July 2025
Estimated Primary Completion Date:	November 2027

Eligibility Criteria

Ages Eligible for Study:	12 Years Old & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Atopic Dermatitis

Inclusion Criteria

Participants who, according to the treating physician’s decision and in line with the local package label, start treatment with nemolizumab (Nemluvio®)
Adolescent and adult participants aged >=12 years with moderate-to-severe AD
Participants who signed the written informed consent form (ICF) or had it signed by their legal representative

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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Moderate-to-Severe Atopic Dermatitis Study (12 Years+)