A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Inclusion Criteria:
Exclusion Criteria:
Prior treatment with dupilumab or tralokinumab
Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
Treatment with any of the following agents within 4 weeks prior to the baseline visit:
Treatment with the following prior to the baseline visit:
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology
History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
North York, Ontario M2M4J5, Canada
Bad Bentheim, North Rhine-Westphalia 48455, Germany
Morelia, Michoacan Morelia CP 58249, Mexico
Niaosong Dist, Kaohsiung City 833, Taiwan
Kharkiv, 61038, Ukraine