20 Dec Atopic Dermatitis : Positive Phase 3 Studies for Tralokinumab in Moderate to Severe Disease
MedicalResearch.com Interview with:
Dr. Kjoeller
Dr Kim Kjoeller MD
Executive Vice President, Global Research & Development
LEO Pharm
Discusses the recent announcement from LEO Pharma A/S that tralokinumab met all primary and secondary endpoints in its three Phase 3 studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis in adults.
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Atopic Dermatitis?
Response: Atopic Dermatitis (AD) – also known as ‘atopic eczema’ – is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions is the most common inflammatory skin disease in the world, with limited effective treatment options, especially for moderate-to-severe patients.
The primary objective of these studies was to evaluate the efficacy of tralokinumab compared with placebo in treating moderate-to-severe atopic dermatitis.
- ECZTRA 1 and 2 evaluated the use of tralokinumab as monotherapy
- ECZTRA 3 evaluated the use of tralokinumab in combination with a topical corticosteroid (TCS).
MedicalResearch.com: How does tralokinumab differ from other treatments of Atopic Dermatitis?
Response: Tralokinumab is an investigational, fully human monoclonal antibody that specifically neutralizes the interleukin (IL)-13 cytokine, and if approved by regulatory authorities, tralokinumab may offer another treatment option for atopic dermatitis patients that are inadequately controlled by topical therapy alone.
By specifically binding to the IL-13 cytokine, tralokinumab prevents its interaction with the receptor and the subsequent downstream IL-13 signalling. The IL-13 cytokine has been found to be overexpressed in the skin of atopic dermatitis patients, and is implicated in the pathophysiology behind the hallmark symptoms of AD skin, such as skin barrier disruption, inflammation, itch and increased risk of skin infections.
MedicalResearch.com: What are the main findings?
Response: We can confirm that tralokinumab met all primary and secondary endpoints in its three pivotal Phase 3 studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (atopic dermatitis) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo.
MedicalResearch.com: What should readers take away from your report?
Response: Atopic dermatitis is the most common inflammatory skin disease in the developed world, affecting up to 5% of adults across the US, Canada, Europe and Japan.
At LEO Pharma, our vision is to build on our dermatology heritage to pioneer and deliver innovative new treatment options to help people with skin diseases, particularly eczema and psoriasis, achieve healthy skin.
We are encouraged by these results, which speak to the potential of tralokinumab as a new long-term treatment solution for patients with moderate-to-severe atopic dermatitis.
MedicalResearch.com: Is there anything else you would like to add?
Response: Full study results will be published when they are presented at a scientific congress or published in a peer-review journal in 2020.
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Last Updated on December 20, 2019 by Marie Benz MD FAAD