Clinical trial NCT06988605: Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults
Official title: Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The clinical decision for treatment with nemolizumab has to be made by the physicians independently of the participation in this NIS and prior to the informed consent process. Participants greater than or equal to (\>=) 12 years of age will be eligible for the trial.

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.

Detailed description: This prospective, multicenter, non-interventional study (NIS) seeks to evaluate treatment with nemolizumab of moderate-to-severe AD in adolescents and 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. 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. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak Pruritus (PP) Numerical Rating Scale (NRS), Average Pruritus (AP) NRS, Sleep Disturbance (SD) NRS, and Pain NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely, and no clinic visits will be required.

Eligibility criteria: 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.

Primary outcomes:
measure: Investigator Global Assessment (IGA) at Month 6
timeFrame: At Month 6
measure: Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6
timeFrame: At Month 6
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI) up to Month 12
timeFrame: Up to Month 12
measure: Scoring Atopic Dermatitis (SCORAD) up to Month 12
timeFrame: Up to Month 12
measure: Investigator Global Assessment (IGA) up to Month 12
timeFrame: Up to Month 12
measure: Peak Pruritus Numerical Rating Scale (PP NRS) up to Month 12
timeFrame: Up to Month 12
measure: Average Pruritus Numerical Rating Scale (AP NRS) up to Month 12
timeFrame: Up to Month 12
measure: Sleep Disturbance Numerical Rating Scale (SD NRS) up to Month 12
timeFrame: Up to Month 12
measure: Pain Numerical Rating Scale (Pain NRS) up to Month 12
timeFrame: Up to Month 12
Other outcomes:
Locations:
Study officials:
References: