Phase 2 Trial Supports Tralokinumab Use in Children With Moderate-to-Severe Atopic Dermatitis

Topline results from the Phase 2 TRAPEDS-1 trial showed that tralokinumab demonstrated favorable pharmacokinetic and safety profiles in children aged 6-11 years with moderate-to-severe atopic dermatitis. The multinational study enrolled 28 children across 11 sites in five countries, evaluating two dosing regimens over 16 weeks. Drug exposure was consistent with expectations and comparable to that seen in older patients with atopic dermatitis, supporting further clinical development of tralokinumab for younger children.

Tralokinumab is a fully human biologic that selectively targets the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.

“Completing the TRAPEDS-1 trial marks an important milestone in our pediatric clinical development program for tralokinumab,” said Sophie Lamle, EVP, Development. “Developing treatments for children requires a strong focus on long-term safety, and TRAPEDS-1 reflects LEO Pharma’s commitment to building the evidence needed to support use in this vulnerable patient group.”

Atopic dermatitis affects up to 20% of children globally. Approximately 90% of patients with atopic dermatitis develop symptoms before the age of 5, and the disease can persist into adulthood.5 In moderate to severe cases, skin lesions can cause intense itching, very dry skin, cracking, changes in skin color, scabbing, fluid leakage, and a higher risk of infection.

Moderate-to-severe atopic dermatitis also significantly impacts the quality of life of affected children as well as their parents and caregivers.

TRAPEDS-1 was a Phase 2, randomized, assessor-blinded, parallel-group, multicenter monotherapy clinical trial designed to characterize the pharmacokinetic profile and assess the safety of tralokinumab in children with moderate-to-severe atopic dermatitis. A total of 28 patients were enrolled across 11 sites in five countries.

During the initial 16-week randomized treatment period, patients received one of two tralokinumab dose regimens. The trial met its primary objective and overall, the pharmacokinetic profile was as expected and consistent with what has previously been observed with tralokinumab.

Patients in the trial were treated with tralokinumab for up to 172 weeks. Following the initial treatment period, all patients entered an open-label phase and continued tralokinumab treatment, and a subsequent off-treatment safety follow-up period of 16 weeks.

Across the initial, open-label, and long-term extension periods, tralokinumab was generally well tolerated, and the safety data observed was consistent with the known safety profile of tralokinumab. The majority of adverse events were non-serious and mild to moderate in severity.

“These results are encouraging, particularly given the long duration of exposure in a pediatric population with significant disease burden,” said 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. “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.”

Detailed results from the TRAPEDS-1 trial will be submitted for scientific presentation and publication at a later date.

A separate Phase 3 trial evaluating the efficacy and safety of tralokinumab in children and infants with moderate-to-severe atopic dermatitis (TRAPEDS-2), is currently ongoing.

The safety and efficacy of tralokinumab in patients aged 6 to 11 has not been evaluated by regulatory agencies.

About the TRAPEDS-1 Trial

The TRAPEDS-1 clinical trial (NCT05388760) is a Phase 2, randomized, assessor-blinded, parallel-group, multicenter clinical monotherapy trial designed to evaluate the pharmacokinetics and safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis. Patients were randomized before entering an initial 16-week treatment period to receive one of two tralokinumab dose regimens. Following this period, all patients entered an open-label treatment phase, which included a long-term extension period and an off-treatment safety follow-up.

In addition to pharmacokinetics and safety, the trial collected exploratory clinical outcome measures, including Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM), to further characterize the treatment experience in this pediatric population.

The primary objective of the TRAPEDS-1 trial was to characterize key pharmacokinetic parameters The secondary objectives were to evaluate safety and immunogenicity, and to evaluate the efficacy of tralokinumab on severity and extent of atopic dermatitis, as well as on patient-reported outcomes, in children with moderate-to-severe atopic dermatitis.