Tralokinumab Phase 2 TRAPEDS-1 Trial Shows Consistent PK, Safety in Children With Atopic Dermatitis

Pharmacokinetic and safety data from the Phase 2 TRAPEDS-1 trial suggest that tralokinumab (Adtralza/Adbry), the selective IL-13 inhibitor currently approved for adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, produces an exposure profile in children aged 6 to 11 years consistent with that observed in older populations. The findings, announced by LEO Pharma on July 9, 2026, represent the longest reported safety exposure dataset for a biologic targeting IL-13 in this age group, with some patients followed for up to 172 weeks.¹

"These results are encouraging, particularly given the long duration of exposure in a pediatric population with significant disease burden," Professor Michael Cork, Professor of Dermatology and Co-Director of Sheffield Dermatology Research at the University of Sheffield and lead investigator of the TRAPEDS-1 trial, said in a press release. "When treating children with chronic inflammatory diseases, clinicians rely on data that provide consistency and reduce uncertainty. The findings observed over years of treatment provide important information to support long-term management in pediatric patients with moderate-to-severe atopic dermatitis."¹

TRAPEDS-1 (NCT05388760) was a Phase 2, randomized, assessor-blinded, parallel-group, multicenter monotherapy trial enrolling 28 patients across 11 sites in five countries. Eligible patients were children aged 6 to 11 years with moderate-to-severe atopic dermatitis.¹

During the initial 16-week randomized treatment period, patients received one of two tralokinumab dose regimens. All patients subsequently entered an open-label treatment phase inclusive of a long-term extension period, followed by a 16-week off-treatment safety follow-up. The primary objective — characterizing key pharmacokinetic parameters — was met, with the observed profile described as expected and consistent with prior tralokinumab data across age groups, according to the company.¹

Secondary objectives included evaluation of safety, immunogenicity, and exploratory efficacy endpoints. Clinical outcome measures collected included the Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and the Patient-Oriented Eczema Measure (POEM). Quantitative efficacy data were not reported in the announcement; detailed results are expected to be submitted for peer-reviewed publication at a later date.

Across all treatment periods, tralokinumab was described as generally well tolerated. The majority of adverse events were characterized as non-serious and mild to moderate in severity, consistent with the drug's established safety profile in adult and adolescent populations.

Atopic dermatitis is among the most prevalent chronic inflammatory skin diseases of childhood, affecting up to 20% of children globally.⁴ Approximately 90% of patients develop symptoms before age 5, and the disease frequently persists into adulthood.⁵ Moderate-to-severe presentations are associated with intense pruritus, skin barrier disruption, secondary infections, and significant impairment of quality of life for both affected children and their caregivers.⁵

Until recently, systemic treatment options for pediatric atopic dermatitis were limited largely to off-label use of systemic immunosuppressants, including cyclosporine and methotrexate, which carry substantial long-term risk profiles in growing children. The approval of dupilumab for children as young as 6 months broadened the targeted biologic landscape, and there is ongoing interest in defining the safety and efficacy profile of additional IL-13–directed agents across younger age groups.

Tralokinumab is a fully human monoclonal antibody that selectively binds to and neutralizes IL-13, a cytokine centrally implicated in the type 2 inflammatory cascade driving atopic dermatitis pathophysiology.²,³ Regulatory agencies have not yet evaluated the safety and efficacy of tralokinumab in the 6-to-11 age group, and TRAPEDS-1 data are not the basis for a current regulatory submission.

The TRAPEDS-1 dataset is notable for its duration — up to 172 weeks of exposure in a pediatric population — though the sample size of 28 patients limits the power to detect uncommon adverse events or draw definitive efficacy conclusions. The trial was not designed or powered as a pivotal efficacy study. Quantitative efficacy outcomes, immunogenicity rates, and adverse event frequencies have not yet been disclosed in peer-reviewed form, constraining independent clinical interpretation at this stage.

The ongoing Phase 3 TRAPEDS-2 trial, which includes both children and infants with moderate-to-severe atopic dermatitis, is expected to provide the efficacy and safety evidence necessary for a potential regulatory submission in younger pediatric patients. Clinicians should await full peer-reviewed publication of TRAPEDS-1 before drawing practice-level conclusions.

References

1. Leo Pharma. LEO Pharma announces key results of Phase 2 TRAPEDS-1 trial evaluating pharmacokinetics and safety of tralokinumab in children with moderate-to-severe atopic dermatitis. News release. July 9, 2026. Accessed July 9, 2026. https://www.leo-pharma.com/media-center/news/2026-trapeds-1-key-results-press-release
2. ClinicalTrials.gov. Tralokinumab Monotherapy for Children With Moderate-to-Severe Atopic Dermatitis — TRAPEDS 1. Identifier: NCT05388760. https://clinicaltrials.gov/study/NCT05388760
3. Adtralza® (tralokinumab). Summary of Product Characteristics. LEO Pharma. July 2026.
4. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62.
5. Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345-360.