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

Sponsor: Galderma R&D

NCT ID: NCT06988605

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 28 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at real-world experience of using nemolizumab (Nemluvio®) to treat moderate-to-severe atopic dermatitis (a type of eczema) in people aged 12 and over. It is run by Galderma R&D.

Who can take part

  • People aged 12 or over with moderate-to-severe atopic dermatitis
  • Starting treatment with nemolizumab (Nemluvio®), as decided by their doctor and in line with the medicine's label
  • The person, or their legal representative, has signed the informed consent form

Who may not be able to

  • People who cannot take nemolizumab (Nemluvio®) according to the medicine's label
  • People who took an experimental (investigational) drug within 3 months before the start of the study
  • People who have taken nemolizumab before
  • People who cannot understand the consent form or complete the study questionnaires due to mental, physical, or language difficulties

What taking part involves

  • • Taking nemolizumab (Nemluvio®) as prescribed by your doctor, in line with the medicine's label
  • • Completing study questionnaires

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
12 Years and over
Who
All
Number of participants
1,000
Started
2025-07-14
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for atopic dermatitis
  • • Clinical study - 1,000 participants
  • • 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

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with atopic dermatitis

Where?

  • • London - Galderma Investigational Site 5408
  • • Southampton - Galderma Investigational Site 6401
  • • Watford - Galderma Investigational Site 6399
  • • Kings Lynn - Galderma Investigational Site 6400
  • • +20 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Atopic Dermatitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Participants who, according to the treating physician's decision and in line with the local package label, start...
  • ✓Adolescent and adult participants aged \>=12 years with moderate-to-severe AD.
  • ✓Participants who signed the written agreement to take part form (ICF) or had it signed by their legal representative.

Who cannot take part

  • ✗Have safety concern(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...
  • ✗Participants who received nemolizumab previously.
  • ✗Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to...
See the full 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 Is This Study? (24 UK sites)

Galderma Investigational Site 5408

London NW3 2QG, United Kingdom

Recruiting

Galderma Investigational Site 6401

Southampton SO16 6YD, United Kingdom

Recruiting

Galderma Investigational Site 6399

Watford WD18 0HB, United Kingdom

Recruiting

Galderma Investigational Site 6400

Kings Lynn PE30 4ET, United Kingdom

Recruiting

Galderma Investigational Site 5131

Harrogate HG2 7SX, United Kingdom

Recruiting

Galderma Investigational Site 6389

Sheffield S10 2TH, United Kingdom

Recruiting

Galderma Investigational Site 6395

London SE5 9RS, United Kingdom

Recruiting

Galderma Investigational Site 6392

Birmingham B15 2GW, United Kingdom

Recruiting

Galderma Investigational Site 6404

Leeds LS9 7TF, United Kingdom

Recruiting

Galderma Investigational Site 6397

York YO31 8HE, United Kingdom

Recruiting

Galderma Investigational Site 6375

Bridgend CF31 1RQ, United Kingdom

Recruiting

Galderma Investigational Site 6388

Epsom KT18 7EG, United Kingdom

Recruiting

Galderma Investigational Site 6394

Harrow HA3 7LT, United Kingdom

Recruiting

Galderma Investigational Site 6393

Kingston upon Thames KT2 7QB, United Kingdom

Recruiting

Galderma Investigational Site 6666

Kirkcaldy KY2 5AH, United Kingdom

NOT_YET_RECRUITING

Galderma Investigational Site 6415

Liverpool L14 5AB, United Kingdom

Recruiting

Galderma Investigational Site 5210

London E11 1NR, United Kingdom

Recruiting

Galderma Investigational Site 6368

London SE1 9RT, United Kingdom

Recruiting

Galderma Investigational Site 6396

Manchester M23 2SY, United Kingdom

Recruiting

Galderma Investigational Site 6402

Metropolitan Borough of Wirral CH49 5PE, United Kingdom

Recruiting

Galderma Investigational Site 5431

Redhill RH1 5RH, United Kingdom

Recruiting

Galderma Investigational Site 6403

Sandbach CW11, United Kingdom

Recruiting

Galderma Investigational Site 5989

Swansea SA2 8QA, United Kingdom

Recruiting

Galderma Investigational Site 5944

Wolverhampton WV10 0QP, United Kingdom

Recruiting

How to Get in Touch

Galderma Research and Development

Sponsor contact

CONTACT

817-961-5000 clinical.studies@galderma.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-11