BALLERUP, Denmark, July 9, 2026
LEO Pharma A/S has announced positive results from the Phase 2 TRAPEDS-1 clinical trial evaluating the pharmacokinetics and long-term safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis. The study successfully met its primary objective, demonstrating that the pharmacokinetic profile of tralokinumab was consistent with previous clinical findings, while the biologic therapy remained generally well tolerated for up to 172 weeks of treatment without identifying any new safety signals. The findings represent an important milestone in LEO Pharma’s pediatric clinical development program and further strengthen the evidence supporting the long-term safety of IL-13 targeted biologic therapy for pediatric patients living with chronic inflammatory skin disease. The company plans to submit the detailed trial results for scientific presentation and publication while continuing development through the ongoing Phase 3 TRAPEDS-2 study.
Phase 2 TRAPEDS-1 Trial Demonstrates Favorable Pharmacokinetics and Long-Term Safety
The TRAPEDS-1 study was a Phase 2 randomized, assessor-blinded, parallel-group, multicenter monotherapy clinical trial designed to evaluate the pharmacokinetics, safety, immunogenicity, and exploratory clinical outcomes of tralokinumab in children with moderate-to-severe atopic dermatitis. The trial enrolled 28 pediatric patients across 11 clinical sites in five countries, where participants received one of two tralokinumab dosing regimens during an initial 16-week randomized treatment period, followed by an open-label extension and long-term treatment for up to 172 weeks, along with a 16-week safety follow-up period.
The study met its primary objective, confirming that the pharmacokinetic characteristics were consistent with previous tralokinumab studies, while the therapy demonstrated a well-established safety profile throughout long-term treatment. Most reported adverse events were non-serious and mild to moderate in severity, with no new safety concerns identified during the study, reinforcing confidence in the biologic’s safety profile for long-term pediatric use.
Long-Term Pediatric Data Supports Future Clinical Development
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Tralokinumab is a fully human monoclonal antibody that selectively inhibits interleukin-13 (IL-13), a cytokine recognized as a key driver of inflammation and symptoms associated with atopic dermatitis. According to LEO Pharma, completing the TRAPEDS-1 trial marks an important advancement in generating long-term pediatric evidence, where treatment safety remains a critical consideration. Atopic dermatitis affects up to 20% of children globally, with most patients developing symptoms before five years of age and many continuing to experience chronic disease into adulthood.
Children with moderate-to-severe atopic dermatitis often suffer from persistent itching, inflamed skin, sleep disruption, increased infection risk, and a significantly reduced quality of life that also impacts families and caregivers. Investigators noted that the consistency of safety observations over several years of treatment provides valuable clinical information that can support long-term disease management while reducing uncertainty for physicians treating pediatric patients with chronic inflammatory skin disorders.
LEO Pharma Advances Pediatric Dermatology Innovation
The positive TRAPEDS-1 results further strengthen LEO Pharma’s commitment to advancing innovative biologic therapies for inflammatory skin diseases while expanding scientific understanding of pediatric atopic dermatitis treatment. Although tralokinumab is currently approved in multiple global markets for adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis, its safety and efficacy in children aged 6 to 11 years have not yet been evaluated by regulatory authorities. The ongoing Phase 3 TRAPEDS-2 clinical trial is expected to provide additional evidence evaluating the efficacy and safety of tralokinumab in children and infants, supporting future regulatory submissions.
By continuing to invest in pediatric dermatology research, LEO Pharma aims to address significant unmet medical needs while advancing precision biologic therapies capable of improving long-term outcomes and quality of life for children living with moderate-to-severe atopic dermatitis worldwide.
Source: LEO Pharma press release
