LEO Pharma Reports Positive Phase 2 TRAPEDS-1 Results for Tralokinumab in Children with Moderate-to-Severe Atopic Dermatitis
LEO Pharma A/S, a global company specializing in medical dermatology, has announced positive topline results from its Phase 2 TRAPEDS-1 clinical trial, which evaluated the pharmacokinetics and safety of tralokinumab in children aged 6 to 11 years with moderate-to-severe atopic dermatitis (AD). The findings represent an important milestone in the company’s efforts to expand treatment options for pediatric patients living with this chronic inflammatory skin disease.
According to the company, the study successfully achieved its primary objective by demonstrating that tralokinumab exhibited the expected pharmacokinetic profile in children while maintaining a safety profile consistent with previous clinical studies conducted in adolescents and adults. Patients participating in the trial received treatment for an extended period of up to 172 weeks, providing valuable long-term safety information in a pediatric population.
The results strengthen LEO Pharma’s ongoing pediatric clinical development program and support the continued evaluation of tralokinumab as a potential treatment option for younger patients with moderate-to-severe atopic dermatitis. Although encouraging, the therapy has not yet been evaluated or approved by regulatory authorities for use in children aged 6 to 11 years.
Expanding Treatment Options for Children
Atopic dermatitis is among the most common chronic inflammatory skin disorders affecting children worldwide. The condition often begins during infancy or early childhood and can persist for many years, sometimes continuing into adulthood.
Current treatment options for children with moderate-to-severe disease remain relatively limited, particularly for those whose symptoms cannot be adequately controlled with topical therapies alone.
Recognizing this unmet medical need, LEO Pharma has been investing in clinical research aimed at evaluating biologic therapies capable of providing targeted treatment while maintaining acceptable long-term safety profiles in younger patients.
The completion of the TRAPEDS-1 study represents an important step in generating the scientific evidence necessary to evaluate tralokinumab in pediatric populations.
Understanding Atopic Dermatitis
Atopic dermatitis is a chronic inflammatory disease characterized by persistent skin inflammation, intense itching, and recurrent flare-ups.
The condition develops through a complex interaction of immune dysregulation, skin barrier dysfunction, genetic susceptibility, and environmental triggers.
Globally, the disease affects up to 20% of children, making it one of the most prevalent chronic pediatric skin disorders.
Approximately 90% of patients develop symptoms before reaching five years of age, highlighting the importance of effective early treatment strategies.
For many children, the disease follows a relapsing course with periods of improvement followed by recurring exacerbations.
The Burden of Moderate-to-Severe Disease
Children with moderate-to-severe atopic dermatitis often experience symptoms that extend far beyond occasional skin irritation.
Clinical manifestations may include:
- Persistent itching
- Extremely dry skin
- Inflamed skin lesions
- Skin cracking
- Changes in skin pigmentation
- Scabbing
- Fluid leakage
- Increased susceptibility to skin infections
Constant itching frequently leads to scratching, further damaging the skin barrier and creating a cycle of inflammation that can become difficult to control.
Sleep disruption is another common consequence, with many children experiencing difficulty sleeping due to nighttime itching.
Poor sleep may contribute to daytime fatigue, reduced concentration, emotional distress, and impaired academic performance.
The disease can also affect social interactions, self-esteem, and overall emotional well-being.
Impact on Families
The burden of pediatric atopic dermatitis extends beyond affected children.
Parents and caregivers often face considerable emotional, financial, and practical challenges associated with managing chronic disease.
Daily treatment routines may involve repeated application of topical medications, moisturizers, dressing changes, and monitoring for infections or disease flare-ups.
Frequent physician visits and ongoing disease management can also place additional demands on families.
As a result, improving disease control has the potential to benefit not only patients but also their caregivers by reducing treatment complexity and improving overall quality of life.
Targeting IL-13 in Atopic Dermatitis
Tralokinumab is a fully human monoclonal antibody designed to selectively target interleukin-13 (IL-13), a cytokine recognized as one of the major drivers of inflammation associated with atopic dermatitis.
IL-13 contributes to several disease mechanisms, including:
- Skin inflammation
- Impaired skin barrier function
- Persistent itching
- Immune dysregulation
By specifically neutralizing IL-13, tralokinumab aims to interrupt these inflammatory pathways while leaving other components of the immune system largely unaffected.
This targeted mechanism distinguishes biologic therapies from broader immunosuppressive treatments and has become an increasingly important approach in dermatology.
Tralokinumab has previously demonstrated efficacy and safety in adult and adolescent populations with moderate-to-severe atopic dermatitis.
About the TRAPEDS-1 Trial
TRAPEDS-1 was designed as a Phase 2, randomized, assessor-blinded, parallel-group, multicenter clinical trial evaluating tralokinumab as monotherapy in children between the ages of 6 and 11 years.
The primary goals of the study were to:
- Characterize the pharmacokinetic profile
- Evaluate safety
- Support dose selection for future pediatric studies
The trial enrolled 28 pediatric patients across 11 clinical sites located in five countries, reflecting an international collaborative effort.
Participants had moderate-to-severe atopic dermatitis requiring systemic treatment consideration.
Study Design
During the initial 16-week randomized treatment period, participants received one of two different tralokinumab dosing regimens.
Researchers evaluated how the drug was absorbed, distributed, metabolized, and eliminated within the pediatric population while simultaneously monitoring safety outcomes.
Following completion of the randomized phase, all patients entered an open-label treatment period, during which every participant continued receiving tralokinumab.
Patients remained on therapy for as long as 172 weeks, allowing investigators to gather valuable long-term safety information.
After discontinuing treatment, participants completed an additional 16-week safety follow-up period to monitor for delayed adverse events.
Positive Pharmacokinetic Findings
According to LEO Pharma, the study successfully achieved its primary endpoint.
Investigators found that tralokinumab demonstrated a pharmacokinetic profile that was consistent with previous observations in older patient populations.
This finding is particularly important because pediatric patients often process medications differently than adults due to developmental differences in body size, metabolism, immune function, and organ maturation.
Establishing predictable pharmacokinetic behavior helps researchers determine appropriate dosing strategies while supporting future efficacy studies.
The results suggest that tralokinumab behaves in children in a manner generally consistent with expectations based on prior clinical development.
Long-Term Safety Results
One of the most significant aspects of the TRAPEDS-1 study was its extended duration.
Because children may require treatment over many years, understanding long-term safety is particularly important when evaluating therapies intended for chronic diseases.
Across the randomized treatment phase, open-label extension, and long-term follow-up, tralokinumab was reported to be generally well tolerated.
Investigators observed a safety profile consistent with previous studies conducted in adults and adolescents.
Most reported adverse events were:
- Non-serious
- Mild in severity
- Moderate in severity
No unexpected safety concerns were identified during the extended treatment period.
These findings provide additional evidence supporting the long-term evaluation of tralokinumab in pediatric patients.
Importance of Long-Term Data
Long-term safety information is especially valuable in pediatric medicine because children often remain on therapy for extended periods while continuing to grow and develop.
Unlike short-duration studies, long-term extension trials help investigators understand whether safety findings remain stable over years of treatment.
Such information can assist physicians in making informed treatment decisions while supporting regulatory evaluation.
The extended exposure achieved in TRAPEDS-1 therefore represents an important contribution to the overall clinical development program.
Expert Perspective
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 study, emphasized the value of consistent long-term data in pediatric inflammatory diseases.
He noted that clinicians managing chronic childhood conditions depend upon evidence that reduces uncertainty regarding long-term treatment.
According to Professor Cork, the results generated over several years of therapy provide important information supporting future management strategies for children with moderate-to-severe atopic dermatitis.
Continuing Pediatric Development
LEO Pharma indicated that detailed analyses from the TRAPEDS-1 study will be submitted for presentation at future scientific conferences and publication in peer-reviewed medical journals.
In parallel, the company continues advancing its broader pediatric development program.
A separate Phase 3 clinical trial, known as TRAPEDS-2, is currently underway.
Unlike TRAPEDS-1, which focused primarily on pharmacokinetics and safety, TRAPEDS-2 is designed to evaluate both the efficacy and safety of tralokinumab in children and infants with moderate-to-severe atopic dermatitis.
The ongoing Phase 3 trial is expected to provide additional evidence regarding the therapy’s potential clinical benefits in younger pediatric populations.
The positive Phase 2 TRAPEDS-1 results represent an important advancement in LEO Pharma’s efforts to develop targeted biologic therapies for children living with moderate-to-severe atopic dermatitis.
The study demonstrated that tralokinumab achieved its primary pharmacokinetic objective while maintaining a favorable long-term safety profile across treatment periods extending up to 172 weeks. These findings contribute valuable scientific evidence supporting continued pediatric investigation of IL-13 inhibition as a treatment strategy for chronic inflammatory skin disease.
Although tralokinumab has not yet received regulatory approval for use in children aged 6 to 11 years, the encouraging results from TRAPEDS-1, together with the ongoing Phase 3 TRAPEDS-2 trial, highlight the company’s commitment to expanding treatment options for pediatric patients. As additional clinical data become available, they will further inform the evaluation of tralokinumab’s potential role in improving outcomes for children and families affected by moderate-to-severe atopic dermatitis.
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.