LEO Pharma Reports Positive Phase II TRAPEDS-1 Data Supporting Long-Term Safety of Tralokinumab in Children with Atopic Dermatitis

LEO Pharma has reported positive topline results from the Phase II 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. The study met its primary objective, demonstrating a pharmacokinetic profile consistent with previous tralokinumab studies. Treatment remained generally well tolerated for up to 172 weeks, with most adverse events being mild to moderate and no new safety signals identified.

The findings provide additional long-term evidence supporting tralokinumab in a pediatric population with significant unmet clinical need. The therapy has not yet been evaluated by regulatory authorities for use in children aged 6 to 11 years.

Expanding an Established Therapy into Younger Patients

Tralokinumab is a fully human monoclonal antibody that selectively binds to and inhibits interleukin-13 (IL-13), a cytokine that plays a central role in the inflammatory processes underlying atopic dermatitis. By specifically neutralizing IL-13, the biologic reduces the immune signaling responsible for chronic skin inflammation, intense itching, and impaired skin barrier function.

The therapy is currently marketed as Adtralza® (marketed as Adbry® in the United States) and is approved in multiple regions, including the European Union and the United States, for the treatment of adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. The pediatric development program aims to extend its use to younger children.

Atopic dermatitis affects up to 20% of children worldwide, with nearly 90% of patients developing symptoms before the age of five. Moderate-to-severe disease can cause persistent pruritus, extensive skin lesions, sleep disturbance, recurrent skin infections, and substantial reductions in quality of life for both patients and caregivers.

 Small Phase II Study Supports Long-Term Safety

The TRAPEDS-1 trial (NCT05388760) was a randomized, assessor-blinded, parallel-group, multicenter Phase II monotherapy study conducted across 11 sites in five countries. The study enrolled 28 children with moderate-to-severe atopic dermatitis who were randomized to receive one of two tralokinumab dosing regimens during a 16-week treatment period before entering an open-label extension and a subsequent 16-week off-treatment safety follow-up.

Although relatively small, the study was intended to characterize pharmacokinetics and evaluate long-term safety rather than establish clinical efficacy. The primary endpoint assessed key pharmacokinetic parameters, while secondary objectives included safety, immunogenicity, disease severity, and patient-reported outcomes. Exploratory assessments incorporated the Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and the Patient-Oriented Eczema Measure (POEM).

Investigators reported that tralokinumab demonstrated the expected pharmacokinetic profile, consistent with previous clinical experience. Treatment remained generally well tolerated throughout the randomized, open-label, and long-term extension periods, with the overall safety profile remaining consistent with that previously established for tralokinumab.

Long-Term Data Address an Important Pediatric Need

Sophie Lamle, Executive Vice President of Development at LEO Pharma, said completion of TRAPEDS-1 represents a significant milestone in the company’s pediatric clinical development program. She noted that establishing long-term safety is particularly important when developing therapies for children with chronic inflammatory diseases and said the study contributes important evidence to support future use in this patient population.

Professor Michael Cork, Professor of Dermatology and Co-Director of Sheffield Dermatology Research at the University of Sheffield and lead investigator of the study, said the extended follow-up provides valuable information for clinicians managing children with chronic atopic dermatitis. He added that consistent long-term safety data help reduce uncertainty when selecting therapies for pediatric patients who may require prolonged treatment.

Phase III Development Continues

LEO Pharma plans to present the detailed TRAPEDS-1 findings at future scientific meetings and submit the results for peer-reviewed publication.

The ongoing Phase III TRAPEDS-2 trial is evaluating the efficacy and safety of tralokinumab in children and infants with moderate-to-severe atopic dermatitis. Together, the TRAPEDS-1 findings and the ongoing Phase III program expand the evidence base supporting tralokinumab in pediatric populations and could support future regulatory submissions to extend the therapy’s approved use to younger children with chronic inflammatory skin disease.

What This Means for Patients

For children aged 6 to 11 years living with moderate-to-severe atopic dermatitis, the Phase II TRAPEDS-1 results provide encouraging evidence that tralokinumab maintained a consistent safety profile during up to 172 weeks of treatment, with no new safety signals identified. Although the study was relatively small and was primarily designed to evaluate pharmacokinetics and long-term safety rather than efficacy, the findings support continued clinical development in younger children. Tralokinumab is already approved for adults and adolescents aged 12 years and older in several countries, and results from the ongoing Phase III TRAPEDS-2 trial will determine whether the therapy could become a future treatment option for younger pediatric patients.

Reference

2026 TRAPEDS-1 key results press release | LEO Pharma