LEO Pharma A/S begins phase 3 clinical study with tralokinumab in adolescent patients with moderate-to-severe atopic dermatitis

BALLERUP, Denmark, 20 July 2018 – LEO Pharma today announced that it has enrolled the first adolescent patients in a new phase 3 clinical study with tralokinumab, an investigational, fully human monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis.

Tralokinumab specifically blocks the effects of the cytokine IL-13 , which plays an important role in the pathophysiology of atopic dermatitis – one of the most common chronic, inflammatory skin diseases . Tralokinumab is not currently licensed in any country for any indication.

ECZTRA 6 (ECZema TRAlokinumab trial no. 6), is a randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in patients between the ages of 12 to 17 years with moderate to severe atopic dermatitis who are candidates for systemic therapy.

A significant number of patients who suffer from atopic dermatitis are under age 18, so it is important to evaluate how a potential new treatment option, such as tralokinumab, works in this age group,” said Amy Paller, MD, Chair, Department of Dermatology, Northwestern University Skin Disease Research Center, Chicago, Illinois. “Safety and tolerability are priorities when considering new treatments for adolescents, so this study will help determine the profile of a biologic that directly targets IL-13 alone.

Further information about trials with tralokinumab can be accessed via https://clinicaltrials.gov.

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About Atopic Dermatitis (AD)

AD is a common type of eczema that affects up to 5 percent of adults across North America, Europe and Japan. It is a chronic, intensely itchy skin disease, characterized by persistent, immune-mediated inflammation and skin barrier defects . AD has a significant, negative impact on the well-being of adult and adolescent patients and their relatives, primarily due to the intense itch which leads to disrupted sleep and other negative consequences5.

Patients with moderate-to-severe AD currently have limited treatment options for long-term control and safety. There is a need for more targeted and well-tolerated treatment options .

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,200 people worldwide.

LinkedIn: www.linkedin.com/company/leo-pharma
YouTube: www.youtube.com/leopharmaglobal


  1. Popovic B, Breed J, Rees DG et al. Structural Characterization Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Ralpha1 and IL-13Ralpha2. J Mol Biol. 2017;429(2):208-219.
  2. Silverberg J, Kantor R. The role of interleukins 4 and/or 13 in the pathophysiology and treatment of atopic dermatitis. Dermatol Clinics 2017; 35:327–334.
  3. Egawa G, Kabashima K. Multifactorial skin barrier deficiency and atopic dermatitis: Essential topics to prevent the atopic march. J Allergy Clin Immunol. 2016;138(2):350-358.
  4. Barbarot S, et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018;73(6):1284-1293
  5. Weidinger S, Novak N. Atopic dermatitis. The Lancet. 2016; 387:1109-22
  6. Nygaard U et al. Emerging treatment options in atopic dermatitis: systemic therapies. Dermatology 2017;233:344-357

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