Denmark-based LEO Pharma reported positive Phase II results from the TRAPEDS-1 study of tralokinumab (Adbry/Adtralza) in children aged 6–11 years with moderate-to-severe atopic dermatitis, demonstrating a pharmacokinetic profile consistent with older patients and no new safety signals. The data provide the first long-term pediatric safety evidence for the anti-IL-13 antibody in this age group and support the company's ongoing Phase III TRAPEDS-2 program.
The Phase II TRAPEDS-1 study enrolled 28 children across 11 sites in five countries. Participants received tralokinumab monotherapy during a 16-week randomized treatment period followed by an open-label extension, with treatment lasting up to 172 weeks.
The trial met its primary endpoint, showing pharmacokinetic exposure comparable to adults and adolescents. Tralokinumab was generally well tolerated, with no new safety signals and a safety profile consistent with previous studies. LEO Pharma did not disclose pharmacokinetic or exploratory efficacy data, which will be presented separately.
The findings address an important requirement for pediatric development by demonstrating that drug exposure in children is consistent with older populations. However, the study was not designed to support regulatory approval or establish efficacy. Those data are expected from the ongoing Phase III TRAPEDS-2 trial, which is evaluating tralokinumab in children and infants with moderate-to-severe atopic dermatitis.