Study will examine the safety and efficacy of tralokinumab monotherapy in treating atopic dermatitis.
A phase 3 trial examining the use of tralokinumab to treat atopic dermatitis is officially underway, according to a press release.
Tralokinumab is an investigational human monoclonal antibody designed to target the cytokine IL-12, which is known to play a key role in the development of moderate-to-severe atopic dermatitis.
The randomized, double-blind, placebo-controlled, phase 3 ECZTRA 1 study is evaluating the safety and efficacy of tralokinumab monotherapy in patients with atopic dermatitis who are candidates for systemic therapy.
“Moderate-to-severe atopic dermatitis is a debilitating skin condition characterized by intense itching, painful lesions, and infections,” Dr Eric Simpson, professor and director of clinical trials and Oregon Health and Science University, said in a release. “Advancements in the treatment of this underserved condition are necessary. In this phase 3 program we will establish how tralokinumab’s specific targeting of IL-13 might offer a potential new treatment for patients with this complex and chronic disease.”
Atopic dermatitis is the most common inflammatory skin disease, with a prevalence in western countries of 1% to 3% in adults and up to 20% in children, according to the release. In a US population-based survey, moderate and severe forms constitute approximately 50% and 20%, respectively.
“Eczema patients are in need of new treatment options,” Julie Block president and CEO of the National Eczema Association, said in a release. “This is a disease with a significant impact on patients’ quality of life, and we welcome LEO Pharma’s investment in new clinical approaches.”
Tralokinumab is part of Leo Pharma’s recent efforts to shift into systemic treatments for skin diseases. The company acquired the global license to tralokinumab in skin diseases from AstraZeneca in July 2016. They acquired an exclusive European license to develop and commercialize brodalumab for the treatment of moderate-to-severe plaque psoriasis.