LEO Pharma reports positive Phase 2 trial results for tralokinumab in children with atopic dermatitis
Friday, July 10, 2026
LEO Pharma has announced positive results from the Phase 2 TRAPEDS-1 trial, which evaluated the pharmacokinetics and safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis.
Tralokinumab is a fully human biologic that selectively targets the interleukin-13 (IL-13) cytokine, which plays a key role in the development of atopic dermatitis.
The completion of the TRAPEDS-1 trial marks an important step in LEO Pharma’s paediatric clinical development programme for tralokinumab. The company said the study adds to the evidence supporting the long-term safety profile of the treatment in children.
Atopic dermatitis affects up to 20% of children worldwide, with around 90% of patients developing symptoms before the age of five. The condition may continue into adulthood. Children with moderate-to-severe disease can experience intense itching, very dry skin, cracking, skin colour changes, scabbing, fluid leakage and an increased risk of infection. The disease can also have a significant impact on the quality of life of patients, their families and caregivers.
TRAPEDS-1 was a Phase 2, randomised, assessor-blinded, parallel-group, multicentre monotherapy study designed to assess the pharmacokinetic profile and safety of tralokinumab. The trial enrolled 28 children across 11 sites in five countries.
During the initial 16-week randomised treatment period, participants received one of two tralokinumab dosing regimens. The study achieved its primary objective, with the pharmacokinetic profile matching previous findings for the medicine.
Patients received tralokinumab treatment for up to 172 weeks. After the initial treatment phase, all participants entered an open-label extension and continued treatment before completing a 16-week off-treatment safety follow-up period.
Across the initial study, open-label phase and long-term extension, tralokinumab was generally well tolerated. The safety findings were consistent with the medicine’s established safety profile, and most reported adverse events were mild to moderate and non-serious.
LEO Pharma said detailed results from the TRAPEDS-1 trial will be submitted for presentation at scientific meetings and for publication in a peer-reviewed journal.
The company is also continuing the Phase 3 TRAPEDS-2 trial, which is evaluating the efficacy and safety of tralokinumab in children and infants with moderate-to-severe atopic dermatitis.
Tralokinumab has not yet been evaluated by regulatory authorities for safety and efficacy in children aged 6 to 11 years.
Source: businesswire.com
