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