Back to search results

Tralokinumab for Moderate-to-Severe Atopic Dermatitis in Children and Infants

This study is testing if tralokinumab, given as an injection under the skin, combined with topical corticosteroids (TCS) is safe and effective for children and infants (ages 6 months to 11 years) with moderate-to-severe atopic dermatitis (eczema). Tralokinumab works by inhibiting a specific protein involved in inflammation. Participants will receive either tralokinumab plus TCS or a placebo (inactive substance) plus TCS. The study aims to see if participants achieve clear or almost clear skin, or a significant reduction in eczema severity, after 16 weeks. The trial is currently recruiting about 195 participants.

Study design
This interventional study is testing tralokinumab plus TCS against a placebo plus TCS. It plans to enroll 195 participants aged 6 months to 11 years.
What's involved
You would have visits every two weeks for the first year, then every six weeks after that. Some visits may be conducted by phone, and the trial could last up to four years.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at week 16, but the trial duration is up to four years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06311682

A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

Recruiting
PHASE3Ages 6–11InterventionalTreatment
LEO Pharma
~195 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Tralokinumab + TCSPlacebo + TCS

At a glance

Recruiting sites
23 of 72 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Measured over At week 16
+1 more outcome measured

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

72 sites across 22 states
Canada10
South Korea9
Poland8
Germany6
Italy5
California4
Belgium4
United Kingdom4

Study leadership

  • Medical Expert · STUDY_DIRECTOR · LEO Pharma

Who to contact

Clinical Disclosure
[email protected]
+45 4494 5888
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.At week 16

    The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  • Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.At week 16

    The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.