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

Not yet recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT06988605
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study Start: 2025-05-21
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-10-21
• Study Completion: 2027-10-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) at Month 6	At Month 6	The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment.
Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6	At Month 6	The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.

Secondary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI) up to Month 12	Up to Month 12	The EASI is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs. The EASI score is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. A higher score indicates severe AD.
Scoring Atopic Dermatitis (SCORAD) up to Month 12	Up to Month 12	The SCORAD is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs and symptoms. The SCORAD ranges from 0 to 103 and has 3 components: extent, intensity, and patient-reported symptoms of pruritus and sleep loss. The investigator or trained designee will assess the severity of 6 signs of AD (erythema, edema/papulation, oozing/crust, excoriation, lichenification, and dryness), each on a scale ranging from 0 (absence) to 3 (severe). The investigator or trained designee will also ask the participant to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a visual analogue scale (VAS) from 0 to 10. A higher score indicates severe AD.
Investigator Global Assessment (IGA) up to Month 12	Up to Month 12	The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment.
Peak Pruritus Numerical Rating Scale (PP NRS) up to Month 12	Up to Month 12	The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.
Average Pruritus Numerical Rating Scale (AP NRS) up to Month 12	Up to Month 12	The AP NRS is a single question assessment that participants will use to report the average intensity of their pruritus (itch). The AP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?". Here, a lower score indicates a better outcome.
Sleep Disturbance Numerical Rating Scale (SD NRS) up to Month 12	Up to Month 12	The SD NRS is a single-item PRO for quantifying sleep disturbance. The SD NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (atopic dermatitis)' and 10 being 'I did not sleep at all due to the symptoms of my skin disease (atopic dermatitis)', how would you rate your sleep last night?". Here, a lower score indicates a better outcome.
Pain Numerical Rating Scale (Pain NRS) up to Month 12	Up to Month 12	The Pain NRS is a single-item assessment with a potential follow-up question that participants will use to report the average intensity of their pain. The Pain NRS consists of the following question: "Over the past 24 hours, how severe was the pain in your skin?". If the participant rates their pain from 1 to 10, then the following question will be asked: "Do you think the pain is part of the itch, from scratching or both?". Here, a lower score indicates a better outcome.