LEO Pharma begins third phase 3 clinical study for tralokinumab in atopic dermatitis


BALLERUP, Denmark, 28 February 2018 – LEO Pharma has today announced that it has enrolled the first patients in a third phase 3 clinical study of 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-131, which plays a central role in the development of atopic dermatitis2,3 – one of the most common chronic, inflammatory skin diseases4. Tralokinumab is not currently licensed in any country for any indication.

ECZTRA 3 (ECZema TRAlokinumab trial no. 3), is a randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

"Topical steroids are commonly used to treat acute flares or lesions caused by atopic dermatitis, while biologics help maintain long-term control of persistent, immune-mediated inflammation,” said Jonathan Silverberg, MD, PhD, Assistant Professor of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. “Patients with moderate-to-severe atopic dermatitis may require both types of therapies to achieve the best results, so it’s important to understand how treatments that specifically target IL-13 alone, in combination with topical corticosteroids, can help, in combination with topical corticosteroids, can help patients in the real world with such a chronic and complex skin disease.”

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



About Atopic Dermatitis (AD)

AD is a common type of eczema that affects up to 10 percent of adults5. It is a chronic, intensely pruritic (itching of the skin without visible eruption) skin disease, characterized by persistent, immune-mediated inflammation and skin barrier defects6. AD has a significant, negative impact on patient well-being primarily due to the intense itch which leads to disrupted sleep and other negative consequences. There is currently a high unmet need for long-term efficacious and well-tolerated treatment options in atopic dermatitis.7



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    Gittler JK, Shemer A, Suarez-Farinas M, et al. Progressive activation of TH2/TH22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. Allergy Clin Immunol. 2012;130:1344-54.

3    Tazawa T, Sugiura H, Sugiura Y et al. Relative importance of IL-4 and IL-13 in lesional skin of atopic dermatitis. Arch Dermatol Res. 2004, 295(11):459-64. 

4    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.

5    Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: A US population–based study. J Allergy Clin Immunol. 2013;132:1132-8.

6    Weidinger S, Novak N. Atopic dermatitis. The Lancet. 2016; 387:1109-22.

7    Q&A with Dr. Silverberg. Ask the Presenter - Conference Report. AJMC 2016.



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