Phase III studies (ECZTRA 1-3) of CAT 354 meet primary endpoint in atopic dermatitis.- LEO Pharma

LEO Pharma announced that CAT 354 (tralokinumab) met all primary and secondary endpoints in its three pivotal Phase III studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo. ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab studies no. 1 and 2), are randomized, double-blind, placebo-controlled, multinational, 52-week studies, which included 802 and 794 adult patients respectively, to evaluate the efficacy and safety of tralokinumab as monotherapy in adults with moderate-to-severe AD who are candidates for systemic therapy. ECZTRA 3 is a randomized, double-blind, placebo-controlled, multinational 32-week study, which included 380 adult patients, to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate-to-severe AD who are candidates for systemic therapy.

The primary endpoints in the three studies were an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin at week 16 and at least a 75 percent or greater change from baseline in their Eczema Area and Severity Index (EASI) score at week 16. A change from baseline to week 16 in SCORing of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS) of at least 4, and Dermatology Life Quality Index (DLQI) were secondary endpoints. LEO Pharma is planning to submit marketing authorization applications for tralokinumab for the treatment of adult patients with moderate-to-severe AD to regulatory agencies in 2020 and plans to submit the detailed results of these studies for presentation at scientific congresses and publication in peer-reviewed medical journals in 2020 as well.