LEO Pharma has dosed patients in a phase 3 clinical study of its investigational human monoclonal antibody tralokinumab.
Tralokinumab is an antibody that specifically targets the cytokine IL-13, which plays an important role in the development of moderate-to-severe atopic dermatitis. LEO pharma noted in its press release that tralokinumab is not currently licensed in any indication.
ECZTRA 1, the first clinical study in the phase 3 clinical programme for tralokinumab in atopic dermatitis, is a randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Dr. Eric Simpson, Dermatology Department at the Oregon Health and Science University, explained that moderate to severe atopic dermatitis is a debilitating skin condition characterised by intense itching, painful skin lesions, and infections. He said that advancements in the treatment of this underserved condition are necessary. “In this phase 3 programme 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.”
Julie Block, President & CEO, National Eczema Association, USA, said: “Eczema patients are in need of new treatment options. This is a disease with a significant impact on patients’ quality of life, and we welcome LEO Pharma’s investment in new clinical approaches.”