In newly-released findings from LEO Pharma, positive topline from the phase 2 TRAPEDS-1 study have demonstrated favorable pharmacokinetic and safety results for treatment with tralokinumab of children aged 6 - 11 years with moderate-to-severe atopic dermatitis.1
Key Takeaways
- Phase 2 TRAPEDS-1 met its primary objective, demonstrating expected pharmacokinetics and a favorable safety profile for tralokinumab in children aged 6–11 years with moderate-to-severe atopic dermatitis.
- Tralokinumab was generally well tolerated during treatment lasting up to 172 weeks, with most adverse events reported as mild to moderate and non-serious.
- The positive findings support continued pediatric development of tralokinumab, with the phase 3 TRAPEDS-2 trial currently evaluating the biologic in children and infants.
The analysis, an investigational study, supports the continued development of the interleukin (IL)-13-targeting biologic agent among younger pediatric populations, with a separate phase 3 analysis already underway.2 Michael Cork, MD, PhD, professor of dermatology and co‑director of Sheffield Dermatology Research at the University of Sheffield, was a lead investigator of the TRAPEDS-1 trial.
How Important Are These New Phase 2 Data for Pediatric Patients with Eczema?
“When treating children with chronic inflammatory diseases, clinicians rely on data that provide consistency and reduce uncertainty,” Cork said in a statement.1 “The findings observed over years of treatment provide important information to support long-term management in pediatric patients with moderate-to-severe atopic dermatitis.”
Among the most common chronic inflammatory skin diseases in the childhood years, atopic dermatitis is known to impact millions of children around the world.3 Symptoms will often take place early in a patient’s life and in more severe cases, can include persistent levels of xerosis, pruritus, skin fissuring, oozing lesions, pigmentary shifts, and recurrent infections. Outside of atopic dermatitis’s physical manifestations, the condition often disrupts childrens’ lives, including sleep, daily activities, and education. Caregivers also face notable burdens.
How Does Tralokinumab Work for Pediatric Patients with Atopic Dermatitis?
Enrollment in the multi-center TRAPEDS-1 trial involved 28 children between the ages of 6 - 11 years, with 11 clinical sites in 5 countries being implemented. Individuals involved were randomly assigned to be given 1 of 2 dosing regimens of tralokinumab therapy within the initial 16-week treatment period. Cork and colleagues looked into the biologic's pharmacokinetic profile and safety prior to transitioning all subjects into an open-label extension. This allowed long-term use of the medication followed by a 16-week post-treatment period of safety observation.
LEO Pharma officials described the study as having attained its main objective, with the treatment demonstrating pharmacokinetic characteristics aligning with expectations. Impacts on patients were described as comparable to those previously reported in older patient populations.1,2 The children evaluated remained on tralokinumab for as long as 172 weeks and throughout the study’s extension phases, providing investigators with a chance to assess long-term safety.
How Safe is Tralokinumab In Children with Eczema?
Across all of the study periods, tralokinumab maintained a safety profile deemed by Cork et al to be consistent with prior clinical data. They found most treatment-emergent adverse events (TEAEs) were reported to be mild or moderate, and the majority were shown to be non-serious TEAEs. There were no unexpected safety data reported by the investigators.
“These results are encouraging, particularly given the long duration of exposure in a pediatric population with significant disease burden,” Cork said in his statement.1
While detailed efficacy and pharmacokinetic analyses have not yet been published, the company described its full study results as slated to be presented at a future scientific meeting.1 They are also submitted for publication in a peer-reviewed journal.
LEO Pharma is continuing to look into pediatric use of tralokinumab for atopic dermatitis during the ongoing phase 3 TRAPEDS-2 trial. Positive data from this analysis could further expand options for therapies in younger patients living with chronic atopic dermatitis.
References
Puerta Durango K, Chiesa Fuxench ZC. Global Burden of Atopic Dermatitis: Examining Disease Prevalence Across Pediatric and Adult Populations World-Wide. Dermatol Clin. 2024 Oct;42(4):519-525. doi: 10.1016/j.det.2024.05.004. Epub 2024 Jul 25. PMID: 39278705.
