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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorGalderma R&D

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Nemolizumab

Trial outcomes

Primary outcomes

1

Investigator Global Assessment (IGA) 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.

Time frame
At Month 6
2

Peak Pruritus Numerical Rating Scale (PP NRS) 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.

Time frame
At Month 6

Secondary outcomes

1

Eczema Area and Severity Index (EASI) 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.

Time frame
Up to Month 12
2

Scoring Atopic Dermatitis (SCORAD) 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.

Time frame
Up to Month 12
3

Investigator Global Assessment (IGA) 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.

Time frame
Up to Month 12
4

Peak Pruritus Numerical Rating Scale (PP NRS) 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.

Time frame
Up to Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.