Topline efficacy and safety results anticipated by early April 2019
MENLO PARK, Calif., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, today announced the completion of patient enrollment in the Phase 2b dose-ranging study evaluating its anti-IL13 monoclonal antibody, lebrikizumab, in patients with moderate-to-severe atopic dermatitis. The company expects to announce topline efficacy and safety results from the study by early April 2019.
"For many living with moderate-to-severe atopic dermatitis, the condition can often be debilitating, with patients finding limited treatment options that are effective at addressing the underlying cause of the disease," said Luis Peña, chief development officer of Dermira. "Given the role of IL-13 in the development of atopic dermatitis, we believe that lebrikizumab’s distinctive molecular profile could deliver a compelling combination of efficacy, safety and convenience to patients living with moderate-to-severe atopic dermatitis. We look forward to sharing the results by early April of next year."
Lebrikizumab Phase 2b Study
The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study is designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and to establish the dosing regimen for a potential 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 in the United States. The study is evaluating three different lebrikizumab treatment dosing arms compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion:
- Group 1: A loading dose of 250 mg of lebrikizumab at week 0, followed by 125 mg of lebrikizumab every four weeks.
- Group 2: A loading dose of 500 mg of lebrikizumab at week 0, followed by 250 mg of lebrikizumab every four weeks.
- Group 3: A loading dose of 500 mg of lebrikizumab at each of weeks 0 and 2, followed by 250 mg of lebrikizumab every two weeks.
- Group 4: Placebo at week 0 and every two weeks thereafter.
The primary endpoint of the study is the percent change in the Eczema Area Severity Index (EASI) from baseline to week 16. Key secondary endpoints that will be evaluated during the 16-week treatment period include: the proportion of patients with a 75 percent improvement from baseline in EASI (EASI-75); the proportion of patients with an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and a reduction of 2 or more points (on a 5-point scale) from baseline; the proportion of patients achieving EASI-50 and EASI-90; and changes in pruritus (itch) and sleep loss scores from baseline, both scored using an 11-point numerical rating scale (NRS). Key inclusion criteria for patients enrolled in this study included chronic atopic dermatitis for at least one year, an EASI score of 16 or greater, an IGA score of 3 or greater, and a body surface area involving at least 10 percent at screening and baseline. Following the end of the 16-week assessment period, patients will be followed for an additional 16 weeks.
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and also includes redness, cracking, dryness and intense, persistent itching. The skin condition can have a negative impact on patients’ mental and physical functioning, limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.
About Lebrikizumab
Lebrikizumab is a novel, humanized monoclonal antibody designed to bind IL-13 with high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodime...
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