Dermira, Inc. announced dosing of the first patient in a Phase 3 study evaluating the safety and efficacy of lebrikizumab in adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis, the most common form of eczema. 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 of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection. The lebrikizumab Phase 3 program includes two identical, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies designed to confirm the safety and efficacy of lebrikizumab as monotherapy in patients with moderate-to-severe atopic dermatitis. The studies are expected to enroll a total of approximately 800 adult and adolescent patients ages 12 years and older with moderate-to-severe atopic dermatitis at approximately 200 sites in the United States, Europe and Asia. Key patient inclusion criteria for the monotherapy studies include the presence of chronic atopic dermatitis for at least one year, an Investigator’s Global Assessment (IGA) score of 3 or 4 (on a 5-point scale ranging from 0 to 4), an Eczema Area Severity Index (EASI) score of 16 or greater and body surface area (BSA) involvement of at least 10 percent at screening and baseline. The studies will evaluate a 250 mg dose of lebrikizumab administered by subcutaneous injection every two weeks, following a loading dose of 500 mg administered at baseline (day 0) and week 2, compared to placebo for 16 weeks (the induction period). Following the end of the 16-week induction period, study patients who respond during the induction period (as evidenced by achievement of an IGA 0/1 response, representing a reduction of 2 or more points in IGA score from baseline to a final score of 0 (clear) or 1 (almost clear), or an EASI-75 response, representing an improvement in EASI score of at least 75% from baseline) will be re-randomized to one of the following treatment groups for an additional 36-week maintenance period: The primary efficacy endpoint of the studies is the percentage of patients with an IGA 0/1 response from baseline to week 16. Key secondary efficacy endpoints that will be evaluated during the 16-week induction period include: the percentage of patients achieving EASI-75; the percentage of patients achieving EASI-90; the percentage of patients with a pruritus (itch) numerical rating (NRS) score of at least 4 at baseline who achieve a reduction of at least 4 points; percentage changes in pruritus and sleep-loss scores; and change in BSA. The company expects to report topline findings from the 16-week induction period in the first half of 2021. In addition to the two monotherapy studies, the company plans to include a study in the Phase 3 program that evaluates lebrikizumab when used in combination with topical corticosteroids. The impact of lebrikizumab treatment on quality of life will also be assessed across a number of additional measures.