Dermira, Inc. announced that detailed primary results from its Phase 2b dose-ranging study of lebrikizumab are being presented during the 39th Annual Fall Clinical Dermatology Conference in Las Vegas, NV. Lebrikizumab is currently being evaluated in a Phase 3 program in adult and adolescent patients with moderate-to-severe atopic dermatitis. Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Ra1/IL-4Ra heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection. About the Lebrikizumab Phase 2b Study: The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study was designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and establish a dosing regimen for the Phase 3 program in patients with moderate-to-severe atopic dermatitis. The study enrolled 280 patients ages 18 years and older with moderate-to-severe atopic dermatitis at 57 sites in the United States. Three different lebrikizumab treatment dosing arms were evaluated, compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion as follows: Group 1: A loading dose of 250 mg of lebrikizumab at baseline (day 0), followed by 125 mg of lebrikizumab every four weeks. Group 2: A loading dose of 500 mg of lebrikizumab at baseline (day 0), followed by 250 mg of lebrikizumab every four weeks. Group 3: A loading dose of 500 mg of lebrikizumab at baseline (day 0) and week 2, followed by 250 mg of lebrikizumab every two weeks. Group 4: Placebo at baseline (day 0) and every two weeks thereafter. The inclusion criteria for patients enrolled in this study included the presence of chronic atopic dermatitis for at least one year, an Eczema Area and Severity Index (EASI) score of 16 or greater, an Investigator’s Global Assessment (IGA) score of 3 or 4 (on a 5-point scale ranging from 0 to 4) and body surface area (BSA) involvement of at least 10% at screening and baseline. The primary endpoint of the study was the percent change in EASI from baseline to week 16. Secondary endpoints that were evaluated during the 16-week treatment period included: the proportion of patients with a 75% improvement from baseline in EASI score (EASI-75); the proportion of patients with a reduction of 2 or more points in IGA score from baseline to a final score of 0 (clear) or 1 (almost clear) (IGA0/1); the proportion of patients achieving EASI-50 and EASI-90; changes in pruritus (itch) and sleep loss scores from baseline, each scored using a numerical rating scale (NRS); and the proportion of patients with an improvement in pruritus NRS score (on an 11-point scale) of at least 4 points from baseline.