Tralokinumab is a high-affinity human monoclonal antibody that binds to and inhibits interleukin-13, a key driver of atopic dermatitis symptoms.
The phase 3 ECZTRA 6 trial evaluating tralokinumab in adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis demonstrated significant improvements to primary and secondary measurements of efficacy, according to the 16-week results of the 52-week trial. Tralokinumab is a high-affinity human monoclonal antibody that binds to and inhibits interleukin-13, a key driver of atopic dermatitis symptoms.
“After 16 weeks, adolescents who received either dose of tralokinumab, without rescue therapy, showed significantly greater improvement in atopic dermatitis signs and symptoms and quality of life compared to those receiving placebo,” said Amy Paller, MD, chair of the Department of Dermatology at Feinberg School of Medicine, Northwestern University, in a press release. “These findings are encouraging, as moderate-to-severe atopic dermatitis can have major physical and psychosocial impacts on adolescents who have limited options for long-term treatment.”
The initial treatment period of the study assessed the efficacy and safety of tralokinumab 150mg (n=98) or 300mg (n=97) every 2 weeks compared to placebo (n=94) in adolescents. According to the investigators, tralokinumab met its primary and secondary endpoints at week 16, with significantly more patients treated with tralokinumab achieving a clinical response.
The data show that 21.4% of the tralokinumab 150 mg group and 17.5% of the tralokinumab 300 mg group achieved clear or almost-clear skin, compared to 4.3% with placebo. Further, 28.6% in the tralokinumab 150 mg group and 27.8% in the tralokinumab 300 mg group achieved 75% or greater disease improvement from baseline compared to 6.4% with placebo.
The study also met all of its secondary endpoints, addressing the extent and severity of atopic dermatitis, achieving at least a 4-point improvement in adolescent weekly average worst daily pruritus NRS score, and health-related quality of life related to dermatological conditions. The overall frequency and severity of adverse events in the trial were comparable across the treatment groups over the 16 weeks evaluated.
“We are encouraged by these results that advance our understanding of tralokinumab in adolescents, many of whom often struggle with the negative emotional and physical impacts of atopic dermatitis,” said Jörg Möller, MD, executive vice president of Global Research and Development at LEO Pharma, in the release. “This is an important milestone for the overall ECZTRA clinical trial program as we expand studies to include younger patients.”
Adtralza® (tralokinumab) achieves primary and secondary endpoints in phase 3 trial of adolescents with moderate-to-severe atopic dermatitis [news release]. Leo Pharma; October 22, 2021. Accessed October 25, 2021. https://www.businesswire.com/news/home/20211022005123/en