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

• TRAPEDS-1 is a Phase 2 trial evaluating the pharmacokinetics and long-term safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis.¹
• The pharmacokinetic profile was as expected and consistent with what has previously been observed with tralokinumab.
• Tralokinumab was generally well tolerated for up to 172 weeks of treatment, with no new safety signals identified.

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the Phase 2 TRAPEDS-1 trial evaluating the pharmacokinetics and safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis.¹

Tralokinumab is a fully human biologic that selectively targets the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.^2,3

“Completing the TRAPEDS-1 trial marks an important milestone in our pediatric clinical development program for tralokinumab,” said Sophie Lamle, EVP, Development. “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.”

Atopic dermatitis affects up to 20% of children globally.⁴ Approximately 90% of patients with atopic dermatitis develop symptoms before the age of 5, and the disease can persist into adulthood.⁵ In moderate to severe cases, skin lesions can cause intense itching, very dry skin, cracking, changes in skin color, scabbing, fluid leakage, and a higher risk of infection.⁵

Moderate-to-severe atopic dermatitis also significantly impacts the quality of life of affected children as well as their parents and caregivers.⁵

TRAPEDS-1 was a Phase 2, randomized, assessor-blinded, parallel-group, multicenter monotherapy clinical trial designed to characterize the pharmacokinetic profile and assess the safety of tralokinumab in children with moderate-to-severe atopic dermatitis. A total of 28 patients were enrolled across 11 sites in five countries.¹

During the initial 16-week randomized treatment period, patients received one of two tralokinumab dose regimens. The trial met its primary objective and overall, the pharmacokinetic profile was as expected and consistent with what has previously been observed with tralokinumab.

Patients in the trial were treated with tralokinumab for up to 172 weeks. Following the initial treatment period, all patients entered an open-label phase and continued tralokinumab treatment, and a subsequent off-treatment safety follow-up period of 16 weeks.

Across the initial, open-label, and long-term extension periods, tralokinumab was generally well tolerated, and the safety data observed was consistent with the known safety profile of tralokinumab. The majority of adverse events were non-serious and mild to moderate in severity.

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

Detailed results from the TRAPEDS-1 trial will be submitted for scientific presentation and publication at a later date.

A separate Phase 3 trial evaluating the efficacy and safety of tralokinumab in children and infants with moderate-to-severe atopic dermatitis (TRAPEDS-2), is currently ongoing.

The safety and efficacy of tralokinumab in patients aged 6 to 11 has not been evaluated by regulatory agencies.

About the TRAPEDS-1 Trial

The TRAPEDS-1 clinical trial (NCT05388760) is a Phase 2, randomized, assessor-blinded, parallel-group, multicenter clinical monotherapy trial designed to evaluate the pharmacokinetics and safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis. Patients were randomized before entering an initial 16-week treatment period to receive one of two tralokinumab dose regimens. Following this period, all patients entered an open-label treatment phase, which included a long-term extension period and an off-treatment safety follow-up.

In addition to pharmacokinetics and safety, the trial collected exploratory clinical outcome measures, including Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM), to further characterize the treatment experience in this pediatric population.

The primary objective of the TRAPEDS-1 trial was to characterize key pharmacokinetic parameters The secondary objectives were to evaluate safety and immunogenicity, and to evaluate the efficacy of tralokinumab on severity and extent of atopic dermatitis, as well as on patient-reported outcomes, in children with moderate-to-severe atopic dermatitis.

About Adtralza® (tralokinumab) / Adbry ® (tralokinumab-ldrm)

Adtralza® (tralokinumab), which is marketed under the tradename Adbry® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^2,3

Adtralza® / Adbry® is approved for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent 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. Adtralza is approved for use in adults with moderate-to-severe atopic dermatitis in Switzerland, Saudi Arabia and Japan.

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin. For more information, visit www.leo-pharma.com.

References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1). Identifier: NCT05388760. https://clinicaltrials.gov/study/NCT05388760.
2. Adtralza^® (tralokinumab). Summary of Product Characteristics. LEO Pharma. July 2026
3. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
4. Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345-360.
5. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351.