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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Galdrma Investigational Site - 7077
  Phoenix, Arizona, United States Recruiting
• Galderma Investigational Site 7060
  Phoenix, Arizona, United States Recruiting
• Galderma Investigational Site - 8535
  Phoenix, Arizona, United States Recruiting
• Galderma Investigational Site 8224
  Fremont, California, United States Recruiting
• Galderma Investigational Site 8553
  Newport Beach, California, United States Recruiting
• Galderma Investigational Site 7059
  Fairfield, Connecticut, United States Recruiting

+58 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Galderma Research and Development
• Email: clinical.studies@galderma.com
• Phone: 817-961-5000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nemolizumab vs placebo in Chinese teens and adults with moderate-to-severe atopic dermatitis

  This study tests whether Nemolizumab can help moderate-to-severe atopic dermatitis in Chinese participants aged 12 and up, compared with a placebo.

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• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

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• Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin

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  Recruiting Replior AB · Grenoble · NCT07909967

• ADBest TREAT Registry for adults with atopic dermatitis

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• How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis

  This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Copenhagen · NCT07807228

• QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis

  This study tests the safety and tolerability of QX-4533, given as a pill, in healthy adults and in patients with moderate-to-severe atopic dermatitis to see how the drug behaves in the body and what side effects may occur.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.