LEO Pharma announced positive topline results from three pivotal phase 3 studies (ECZTRA 1-3) of tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
ECZTRA 1 and ECZTRA 2 are 52-week, randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of tralokinumab as monotherapy in 802 and 794 adult patients, respectively. ECZTRA 3 is a 32-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tralokinumab in combination with topical corticosteroids in 380 adult patients.
The primary end points for all 3 studies were an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) at week 16 and at least a 75% or greater change from baseline in the Eczema Area and Severity Index (EASI) score at week 16. Secondary end points included change from baseline in SCORing of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS) of at least 4, and Dermatology Life Quality Index (DLQI).
Results from all 3 studies showed that tralokinumab met all primary and secondary end points. Full detailed results will be submitted for presentation at scientific congresses and for publication in peer-reviewed medical journals in 2020. Additionally, the Company plans to submit marketing authorization applications for tralokinumab for adult patients with moderate-to-severe AD to regulatory agencies in 2020.
Regarding safety, tralokinumab showed an overall adverse event rate that was comparable to placebo.
“Despite recent treatment advances, we consistently hear from healthcare professionals around the world that additional treatment options are needed to address the different signs and symptoms for each patient,” said Dr Kim Kjoeller, Executive VP, Global Research & Development, LEO Pharma. We are encouraged by these study results, which show that tralokinumab could be an efficacious and well-tolerated long-term treatment solution for patients living with this debilitating chronic skin disease.”
Tralokinumab is a fully human, immunoglobulin (Ig)G4 monoclonal antibody (mAb) that specifically neutralizes the interleukin-13 (IL-13) cytokine, preventing the subsequent IL-13 signaling, which plays a central role in AD.
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