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New shot could tame severe eczema in kids as young as 6 months

NCT ID NCT06311682

Disease control Sponsor: LEO Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests whether a drug called tralokinumab, given as a shot along with steroid cream, can safely control moderate-to-severe eczema in children aged 6 months to under 12 years. About 195 participants will receive either the drug or a placebo for 16 weeks, then all will get the drug. The trial lasts up to 4 years and tracks skin clearance and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tralokinumab (a biologic drug given as a shot) plus topical corticosteroids (steroid cream)
What this could lead to
If it works, this could provide a new treatment option for young children and infants with hard-to-control eczema, potentially reducing itch and skin flares.
What could go wrong
This is an early-phase trial in a small group, so results may not apply to all children. The drug requires regular injections and may cause side effects like injection reactions or infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

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 months 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: * Age 6 months to \<12 years at screening. * Body weight ≥9 kg at screening. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. * History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to \<6 years at screening. * Documented inadequate response to mid-strength TCS within 6 months before the screening visit. * AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD. * An EASI score of ≥16 at screening and baseline. * An IGA score of ≥3 at screening and baseline. * A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged \<6 years at screening) during the week prior to baseline. Exclusion Criteria: * Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline. * Treatment with bleach baths within 1 week prior to baseline. * Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline. * Use of tanning beds or phototherapy within 4 weeks prior to baseline. * Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit. * Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis. * Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit. * History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Leo Pharma Investigational site

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Leo Pharma Investigational site

    RECRUITING

    North Little Rock, Arkansas, 72117, United States

  • Leo Pharma Investigational site

    RECRUITING

    Palo Alto, California, 94304, United States

  • Leo Pharma Investigational site

    RECRUITING

    Sacramento, California, 95816, United States

  • Leo Pharma Investigational site

    WITHDRAWN

    San Diego, California, 92108, United States

  • Leo Pharma Investigational site

    RECRUITING

    San Diego, California, 92123, United States

  • Leo Pharma Investigational site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Leo Pharma Investigational site

    RECRUITING

    Miami, Florida, 33156, United States

  • Leo Pharma Investigational site

    RECRUITING

    Tampa, Florida, 33613, United States

  • Leo Pharma Investigational site

    RECRUITING

    Macon, Georgia, 31217, United States

  • Leo Pharma Investigational site

    RECRUITING

    Waterford, Michigan, 48328, United States

  • Leo Pharma Investigational site

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Leo Pharma Investigational site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Leo Pharma Investigational site

    RECRUITING

    Charleston, South Carolina, 27420, United States

  • Leo Pharma Investigational site

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Leo Pharma Investigational site

    WITHDRAWN

    Brussels, 1020, Belgium

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Ghent, 9000, Belgium

  • Leo Pharma Investigational site

    WITHDRAWN

    Leuven, 3000, Belgium

  • Leo Pharma Investigational site

    WITHDRAWN

    Liège, 4000, Belgium

  • Leo Pharma Investigational site

    RECRUITING

    Burlington, L7L 6W6, Canada

  • Leo Pharma Investigational site

    WITHDRAWN

    Calgary, Calgary, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Calgary, T2J 7E1, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Edmonton, T5J 3S9, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Edmonton, T6G 1C3, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Hamilton, L8S 1G5, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Niagara Falls, L2H 1H5, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Saskatoon, S7K 2C1, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Windsor, N8X2G1, Canada

  • Leo Pharma Investigational site

    RECRUITING

    Winnipeg, R3M 3Z4, Canada

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Rijeka, 51000, Croatia

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Zagreb, 10000, Croatia

  • Leo Pharma Investigational site

    WITHDRAWN

    Zagreb, 10000, Croatia

  • Leo Pharma Investigational site

    WITHDRAWN

    Buxtehude, 21614, Germany

  • Leo Pharma Investigational site

    WITHDRAWN

    Dresden, 01307, Germany

  • Leo Pharma Investigational site

    WITHDRAWN

    Mainz, 55131, Germany

  • Leo Pharma Investigational site

    WITHDRAWN

    Osnabrück, 49074, Germany

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Tübingen, 72076, Germany

  • Leo Pharma Investigational site

    WITHDRAWN

    Wuppertal, 42283, Germany

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Cork, T12 DFK4, Ireland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Crumlin, D12N512, Ireland

  • Leo Pharma Investigational site

    WITHDRAWN

    Ancona, 60126, Italy

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Brescia, 25123, Italy

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Padova, 35128, Italy

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Roma, 00168, Italy

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Rome, 00165, Italy

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Utrecht, 3584 CW, Netherlands

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Gdansk, 80-546, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Krakow, 30-002, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Lodz, 90-436, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Rzeszów, 35-055, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Tarnów, 33-100, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-953, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-962, Poland

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Brasov, 500091, Romania

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Iași, 700259, Romania

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Ansan-si, 15355, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Gwangju, 61453, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Seoul, 02447, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Seoul, 03080, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Seoul, 03722, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Seoul, 05030, South Korea

  • Leo Pharma Investigational site

    WITHDRAWN

    Seoul, 06273, South Korea

  • Leo Pharma Investigational site

    WITHDRAWN

    Seoul, 06591, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Seoul, 139-711, South Korea

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Alicante, 03010, Spain

  • Leo Pharma Investigational site

    WITHDRAWN

    Madrid, 28046, Spain

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Valencia, 46014, Spain

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Lincoln, LN2 5QY, United Kingdom

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    London, WC1N 3JH, United Kingdom

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Leo Pharma Investigational site

    ACTIVE_NOT_RECRUITING

    Southampton, SO16 6YD, United Kingdom

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