LEO Pharma Reports Positive Phase 2 Pediatric Data for Tralokinumab in Atopic Dermatitis

LEO Pharma has announced positive topline results from the Phase 2 TRAPEDS-1 trial evaluating the pharmacokinetics and long-term safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis (AD). 

Phase 2 Trial Supports Long-Term Safety in Pediatric Population

According to the company, the study met its primary objective, demonstrating a pharmacokinetic profile consistent with previous findings for tralokinumab and a safety profile that remained consistent throughout long-term follow-up. The study was a randomized, assessor-blinded, parallel-group, multicenter Phase 2 monotherapy trial included 28 children recieving 1 of 2 tralokinumab dosing regimens during an initial 16-week randomized treatment period before entering an open-label extension, allowing treatment for up to 172 weeks followed by a 16-week off-treatment safety follow-up.

Across the randomized, open-label, and long-term extension phases, tralokinumab was generally well tolerated, with no new safety signals identified. Most adverse events were reported as non-serious and mild to moderate in severity, according to LEO Pharma. Exploratory assessments included Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM), although efficacy outcomes were not reported in the announcement.

"These results are encouraging, particularly given the long duration of exposure in a pediatric population with significant disease burden," said Michael Cork, MD, Professor of Dermatology and Co-Director of Sheffield Dermatology Research at the University of Sheffield and lead investigator of the study, in the company announcement.

Source

LEO Pharma A/S press release. July 9, 2026.