New study tests 2-Year dupilumab treatment for Kids' eczema
NCT ID NCT05983068
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at how well dupilumab (Dupixent) works over two years in about 48 children aged 6 to 14 with moderate-to-severe eczema. The main goal is to see if the drug improves the skin's barrier function, measured by water loss through the skin. All participants receive dupilumab, and the study tracks safety and skin changes over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent)
- What this could lead to
- If successful, this could show that long-term dupilumab use improves skin barrier function in children with eczema, supporting its continued use for disease control.
- What could go wrong
- This is a small, open-label study with no placebo group, so results may not be definitive. Side effects like injection reactions or infections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age * For new participants: ≥6 to \<12 years of age (inclusive), at the time of signing the informed consent. * For former PELISTAD participants: ≥6 to \<15 years of age at the time of signing the informed consent. Type of participant and disease characteristics * With AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. * Applicable to new participants only: Validated Investigator Global Assessment for AD (vIGA AD™) score of ≥3 (for US and Canada participants) or ≥4 (for UK participants) at screening (on the 0 to 4 scale) depending on the approved vIGA-AD™ label indication in the country. * Applicable to new participants only: Have active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation ≥2 at screening on the 0 to 3 scale of the ISS. * Applicable to all participants: Should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible. * Willing to refrain from applying any topical medications on the target assessment areas (including lesional and non-lesional) throughout the study until EoS unless necessary to alleviate intolerable symptoms. * Willing and able to comply with all clinic visits and study-related procedures. Weight * Body weight ≥15 kg at screening. Exclusion Criteria: Medical conditions * Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis). * Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments. * Hypersensitivity to the active substance or to any of the excipients of dupilumab. * Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. * History of hypersensitivity reaction to skin tape or adhesives used in tape strip discs. Prior/concomitant therapy * Treatment with any investigational medication other than dupilumab within 16 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer. * Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors or phototherapy within 4 weeks of baseline. * Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the Investigator. * Participants who received a live vaccine within 4 weeks of baseline. Prior/concurrent clinical study experience * Current participation in another investigational or interventional clinical study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational Site Number : 8260001
Sheffield, S10 2TH, United Kingdom
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NYU Langone Medical Center- Site Number : 8400004
New York, New York, 10016, United States
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National Jewish Health Medical Center- Site Number : 8400001
Denver, Colorado, 80206, United States
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SSM Health Saint Louis University Hospital- Site Number : 8400006
St Louis, Missouri, 63104, United States
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