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New drug trial aims to tame severe eczema in kids

NCT ID NCT05388760

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

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

Anyone

Healthy volunteers

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

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

  • LEO Pharma Investigational Site

    Brno, 625 00, Czechia

  • LEO Pharma Investigational Site

    Prague, 150 06, Czechia

  • LEO Pharma Investigational Site

    Reims, Ardennes, 51100, France

  • LEO Pharma Investigational Site

    Rotterdam, 3011 TG, Netherlands

  • LEO Pharma Investigational Site

    Utrecht, 3584 CX, Netherlands

  • LEO Pharma Investigational Site

    Cadiz, Andalusia, 11009, Spain

  • LEO Pharma Investigational Site

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • LEO Pharma Investigational Site

    Alicante, 03010, Spain

  • LEO Pharma Investigational Site

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • LEO Pharma Investigational Site

    London, SE1 9RT, United Kingdom

  • LEO Pharma Investigational Site

    Sheffield, S10 2TH, United Kingdom

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