Tralokinumab Meets Pharmacokinetic Goal in Pediatric AD Phase 2 Trial

LEO Pharma recently announced positive results from the phase 2 TRAPEDS-1 trial evaluating the pharmacokinetics and safety of tralokinumab (Adbry) in children aged 6 to 11 years with moderate to severe atopic dermatitis (AD). The trial met its primary objective, with a pharmacokinetic profile as expected and consistent with data previously observed with tralokinumab. Tralokinumab was generally well tolerated for up to 172 weeks of treatment, with no new safety signals identified, according to LEO Pharma.¹

Tralokinumab is a fully human biologic selectively targeting IL-13 and is already approved for moderate to severe AD in patients aged 12 years and older who are candidates for systemic therapy in the European Union, United States, Canada, the United Arab Emirates, and South Korea.^1-3 A separate phase 3 trial, TRAPEDS-2, evaluating the efficacy and safety of tralokinumab in children and infants, is currently ongoing.¹

TRAPEDS-1 (NCT05388760) is a phase 2, randomized, assessor-blinded, parallel-group, multicenter monotherapy trial designed to characterize the pharmacokinetic profile and evaluate the safety of tralokinumab in children aged 6 to 11 years with moderate to severe AD. Investigators enrolled 28 patients across 11 sites in 5 countries. During an initial 16-week randomized treatment period, patients received one of 2 tralokinumab dose regimens.¹

Following this period, all patients entered an open-label extension, continuing tralokinumab treatment for up to 172 weeks total, followed by a 16-week off-treatment safety follow-up. The primary objective, characterization of key pharmacokinetic parameters, was met, with overall exposure as expected and consistent with pharmacokinetic data previously observed with tralokinumab.¹

Secondary objectives included safety, immunogenicity, and exploratory efficacy measures, including Investigator's Global Assessment, Eczema Area and Severity Index, SCORing Atopic Dermatitis, and Patient-Oriented Eczema Measure scores.¹

Tralokinumab Safety Profile in Pediatric AD

Across the initial, open-label, and long-term extension periods, tralokinumab was generally well tolerated in the pediatric population, with a safety profile consistent with prior tralokinumab data, according to LEO Pharma. The majority of adverse events were non-serious and mild to moderate in severity, and no new safety signals emerged over the treatment period. The pediatric safety profile aligns with the established profile of tralokinumab in adults and adolescents aged 12 years and older, for whom the therapy is approved in multiple markets under the brand names Adtralza and Adbry.¹

Detailed results from TRAPEDS-1, including exploratory efficacy findings, will be submitted for scientific presentation and publication at a later date. The safety and efficacy of tralokinumab in patients aged 6 to 11 years has not yet been evaluated by regulatory agencies.¹

"These results are encouraging, particularly given the long duration of exposure in a pediatric population with significant disease burden. When treating children with chronic inflammatory diseases, clinicians rely on data that provide consistency and reduce uncertainty,” said Michael Cork, MD, professor of dermatology and co-director of Sheffield Dermatology Research at the University of Sheffield, and lead investigator of the TRAPEDS-1 trial, in the news release. “The findings observed over years of treatment provide important information to support long-term management in pediatric patients with moderate-to-severe atopic dermatitis."¹

The long-term dataset adds to the pediatric development program for tralokinumab as clinicians await efficacy data from the ongoing TRAPEDS-2 trial in younger children and infants. Confirmation of an expected pharmacokinetic profile in this age group supports continued evaluation of tralokinumab as a potential systemic option for moderate to severe AD earlier in the disease course.¹

“Completing the TRAPEDS-1 trial marks an important milestone in our pediatric clinical development program for tralokinumab,” said Sophie Lamle, executive vice president of development for LEO Pharma, in the news release. “Developing treatments for children requires a strong focus on long-term safety, and TRAPEDS-1 reflects LEO Pharma’s commitment to building the evidence needed to support use in this vulnerable patient group.”¹

Tralokinumab in the News

Recently, tralokinumab was included in the American Academy of Dermatology’s (AAD) first-ever pediatric AD guidelines. Tralokinumab received a strong recommendation from the guidelines for pediatric patients aged 12 years and older with moderate to severe AD. Other monoclonal antibodies that received strong recommendations were dupilumab (Dupixent; Sanofi/Regeneron Pharmaceuticals), lebrikizumab (Ebglyss; Eli Lilly and Company), and nemolizumab (Nemluvio; Galderma Laboratories).⁴

References

1. 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. News release. LEO Pharma. July 9, 2026. Accessed July 10, 2026. https://www.leo-pharma.com/media-center/news/2026-trapeds-1-key-results-press-release
2. Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1). ClinicalTrials.gov; NCT05388760. National Library of Medicine (US). Accessed July 10, 2026. https://clinicaltrials.gov/study/NCT05388760
3. LEO Pharma Inc. announces U.S. FDA approval of Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12-17 years. News release. LEO Pharma. December 15, 2023. Accessed July 10, 2026. https://www.businesswire.com/news/home/20231215374551/en/LEO-Pharma-Inc.-Announces-U.S.-FDA-approval-of-Adbry-tralokinumab-ldrm-for-the-Treatment-of-Moderate-to-severe-Atopic-Dermatitis-in-Pediatric-Patients-Aged-12-17-Years
4. Davis DMR, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in pediatric patients. J Am Acad Dermatol. Published online April 7, 2026. doi:10.1016/j.jaad.2026.02.113

Frequently Asked Questions

What is tralokinumab approved for?
Tralokinumab (Adbry) is approved for moderate-to-severe atopic dermatitis in patients 12 years and older who are candidates for systemic therapy in the European Union, United States, Canada, the United Arab Emirates, and South Korea.

How does tralokinumab work?
Tralokinumab is a fully human monoclonal antibody that binds to and inhibits interleukin (IL)-13, a cytokine involved in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.

What did the TRAPEDS-1 trial show?
TRAPEDS-1 met its primary objective, with a pharmacokinetic profile in children aged 6 to 11 years as expected and consistent with prior tralokinumab data, and the drug was generally well tolerated for up to 172 weeks with no new safety signals.