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Nemolizumab for moderate-to-severe atopic dermatitis in adolescents and adults

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

Observational Galderma R&D · NCT06988605

This will try nemolizumab in adolescents and adults with moderate-to-severe atopic dermatitis to see if it improves symptoms and patient-reported outcomes over six months.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages12 Years and up
SexAll
SponsorGalderma R&D Industry-sponsored
Drugs / interventionsnemolizumab
Locations108 sites (Birmingham, Alabama and 107 other locations)
Trial IDNCT06988605 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-interventional observational study following adolescents and adults (≥12 years) with moderate-to-severe atopic dermatitis who begin nemolizumab treatment per their physician’s decision. Treatment and visit timing follow routine clinical practice, with data collected from physician assessments and patient-reported outcome measures over approximately 12 months and a primary effectiveness readout at Month 6. No extra clinic visits or tests beyond usual care are required, although a remote sub-study in selected sites in Germany and the UK collects daily symptom ratings from Day -1 to Day 14. Prior use of nemolizumab or recent investigational drugs excludes participation, and informed consent is required.

Who should consider this trial

Good fit: Adolescents and adults aged 12 years and older with moderate-to-severe atopic dermatitis who are starting nemolizumab treatment according to their physician and can complete study questionnaires are ideal candidates.

Not a fit: People with contraindications to nemolizumab, prior treatment with nemolizumab, recent participation in other investigational drug trials, or who cannot complete consent or patient-reported measures are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, this could show real-world symptom and quality-of-life improvements with nemolizumab for people with moderate-to-severe atopic dermatitis.

How similar studies have performed: Randomized clinical trials of nemolizumab have shown reductions in itch and clinical signs, so this observational work aims to confirm those effects in routine care.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic Dermatitis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.