Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

Details

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.

Keywords

Atopic Dermatitis, Nemolizumab

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Galderma Investigational Site 7099 not yet accepting patients
    Los Angeles California 90024-2801 United States
  • Galderma Investigational Site 7064 not yet accepting patients
    Santa Monica California 90404-2216 United States
  • Galderma Investigational Site 7107 not yet accepting patients
    Thousand Oaks California 91360-7746 United States
  • Galderma Investigational Site 8553 accepting new patients
    Newport Beach California 92663-3606 United States
  • Galderma Investigational Site 8848 accepting new patients
    Las Vegas Nevada 89144-0518 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Galderma R&D
Links
Sign up for this study
ID
NCT06988605
Study Type
Observational
Participants
Expecting 1000 study participants
Last Updated