New drug trial aims to tame severe eczema in kids
NCT ID NCT05388760
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a drug called tralokinumab in 28 children aged 6 to 12 with moderate-to-severe eczema. The goal was to see how the drug moves through the body and if it is safe. Children received injections over several weeks and used moisturizers daily. The trial is complete, but results are not yet public.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tralokinumab
- What this could lead to
- If successful, this could provide a new treatment option for children with moderate-to-severe eczema that is not well controlled by creams.
- What could go wrong
- This is a small, early-phase trial (Phase 2) with only 28 children, so results may not apply to all. The drug may cause side effects or not work as hoped.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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28 people
The number who actually took part.
- Started
-
Sep 2022
- Finished
-
Apr 2026
- Lead sponsor
-
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
-
6 to 11 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: * Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD). * Age 6 to \<12 years at time of the baseline visit. * Body weight at baseline of ≥17 kg. * History of AD for ≥ 12 months at screening. * History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable. * AD involvement of ≥10% body surface area at screening and baseline. * An EASI score of ≥16 at screening and at baseline. * An Investigator's Global Assessment (IGA) score of ≥3 at screening and at baseline. * Emollient twice daily (or more) for at least 14 days prior to baseline. Exclusion Criteria: * Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment. * Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization. * Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline: * Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). * Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery). * 3 or more bleach baths during any week within the 4 weeks. * Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): * Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. * Other biologics (including dupilumab): within 3 months or 5 halflives, whichever is longer, prior to baseline. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit. * History of malignancy at any time before the baseline visit. * History of anaphylaxis following any biological therapy. * History of immune complex disease. * Active or suspected endoparasitic infections. * History of past or current tuberculosis or other mycobacterial infection. * Established diagnosis of a primary immunodeficiency disorder.
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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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LEO Pharma Investigational Site
Brno, 625 00, Czechia
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LEO Pharma Investigational Site
Prague, 150 06, Czechia
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LEO Pharma Investigational Site
Reims, Ardennes, 51100, France
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LEO Pharma Investigational Site
Rotterdam, 3011 TG, Netherlands
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LEO Pharma Investigational Site
Utrecht, 3584 CX, Netherlands
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LEO Pharma Investigational Site
Cadiz, Andalusia, 11009, Spain
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LEO Pharma Investigational Site
Esplugues de Llobregat, Barcelona, 08950, Spain
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LEO Pharma Investigational Site
Alicante, 03010, Spain
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LEO Pharma Investigational Site
Manchester, Greater Manchester, M13 9WL, United Kingdom
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LEO Pharma Investigational Site
London, SE1 9RT, United Kingdom
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LEO Pharma Investigational Site
Sheffield, S10 2TH, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
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- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?