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Evaluating Tralokinumab with Corticosteroids for Atopic Dermatitis in Children

A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)

Phase 3 Interventional LEO Pharma · NCT06311682

This study is testing if a new injection combined with skin creams can help children and infants with moderate-to-severe eczema feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment195 (estimated)
Ages6 Months to 11 Years
SexAll
SponsorLEO Pharma Industry-sponsored
Drugs / interventionsmethotrexate, tralokinumab
Locations72 sites (Birmingham, Alabama and 71 other locations)
Trial IDNCT06311682 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the safety and efficacy of tralokinumab, a subcutaneous injection, in combination with topical corticosteroids for treating moderate-to-severe atopic dermatitis in children and infants. The study will involve two age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. Participants will be monitored over a period of up to 4 years, with assessments every two weeks for the first year and every six weeks thereafter. The effectiveness of the treatment will be evaluated through various measures of dermatitis severity, symptoms, and overall health status.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to under 12 years with a diagnosis of moderate-to-severe atopic dermatitis and inadequate response to previous treatments.

Not a fit: Patients who have not experienced inadequate responses to topical corticosteroids or who have other skin conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate-to-severe atopic dermatitis in young patients.

How similar studies have performed: Other studies have shown promise in using biologic treatments for atopic dermatitis, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic Dermatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.