TRAPEDS-1 evaluates tralokinumab in children with atopic dermatitis

LEO Pharma reported that tralokinumab demonstrated expected pharmacokinetics and no new safety findings in the phase 2 TRAPEDS-1 trial involving children aged 6 to 11 years with moderate-to-severe atopic dermatitis. However, detailed results have not been published, and the drug has not been evaluated by regulatory agencies for this age group.¹

“Completing the TRAPEDS-1 trial marks an important milestone in our pediatric clinical development program for tralokinumab,” Sophie Lamle, executive vice president of development at LEO Pharma, said in the company announcement.¹

TRAPEDS-1 (NCT05388760) was a randomized, assessor-blinded, parallel-group, multicenter monotherapy study conducted at 11 sites in 5 countries. The trial enrolled 28 children and was designed primarily to characterize the pharmacokinetics of tralokinumab, a fully human monoclonal antibody that binds and inhibits interleukin (IL)-13.¹,²

During the initial 16-week randomized period, participants received 1 of 2 tralokinumab dose regimens. All patients subsequently entered an open-label treatment phase that included a long-term extension, followed by 16 weeks of off-treatment safety follow-up. Total exposure to tralokinumab could extend to 172 weeks.¹,²

According to LEO Pharma, the trial met its primary objective, with a pharmacokinetic profile that was expected and consistent with previous experience with tralokinumab. The company did not disclose pharmacokinetic values, dose-specific findings, immunogenicity results, or between-group comparisons in its announcement.¹

Across the randomized, open-label, and extension periods, tralokinumab was described as generally well tolerated. Most adverse events were nonserious and mild to moderate, and the observed safety findings were characterized as consistent with the established tralokinumab safety profile. Specific adverse-event rates, serious events, treatment discontinuations, and laboratory findings were not reported.¹

The study also collected exploratory measures of disease activity and patient experience, including Investigator’s Global Assessment, Eczema Area and Severity Index, SCORing Atopic Dermatitis, and Patient-Oriented Eczema Measure scores. No efficacy results from those assessments were included in the initial report.

Atopic dermatitis affects up to 20% of children worldwide and frequently begins during early childhood.³ Moderate-to-severe disease can involve persistent pruritus, xerosis, fissuring, exudation, pigmentary changes, and increased susceptibility to cutaneous infection. The associated sleep disruption and chronic symptom burden can also affect children and their caregivers.³

Tralokinumab selectively targets IL-13, a type 2 inflammatory cytokine implicated in atopic dermatitis pathogenesis and skin-barrier dysfunction.⁴ Marketed as Adbry in the United States and Adtralza elsewhere, it is approved for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years or older who are candidates for systemic therapy in several jurisdictions. Approvals in some countries remain limited to adults.¹

The findings offer long-duration exposure information in a small pediatric cohort but are not sufficient to establish efficacy or comparative benefit in children aged 6 to 11 years. The open-label extension also limits interpretation of later safety and clinical outcomes, while the 28-patient sample may not identify uncommon adverse events.

Detailed TRAPEDS-1 results are expected to be submitted for scientific presentation and publication. A separate phase 3 study, TRAPEDS-2, is evaluating tralokinumab efficacy and safety in children and infants with moderate-to-severe atopic dermatitis. Regulatory decisions for younger children will require evaluation of the complete clinical data.

References

1. LEO Pharma. LEO Pharma announces key results of phase 2 TRAPEDS-1 trial evaluating pharmacokinetics and safety of tralokinumab in children with moderate-to-severe atopic dermatitis. Business Wire. July 9, 2026. Accessed July 10, 2026. https://www.businesswire.com/news/home/20260709813013/en/LEO-Pharma-Announces-Key-Results-of-Phase-2-TRAPEDS-1-Trial-Evaluating-Pharmacokinetics-and-Safety-of-Tralokinumab-in-Children-With-Moderate-to-Severe-Atopic-Dermatitis

2. ClinicalTrials.gov. Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis—TRAPEDS 1. NCT05388760. https://clinicaltrials.gov/study/NCT05388760

3. Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345-360.

4. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54-62.