A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Inclusion Criteria:
Exclusion Criteria:
Participation in a prior lebrikizumab clinical study.
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.
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
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.
Los Angeles, California 90025, United States
Los Angeles, California 90033, United States
Dresden, Saxony 01307, Germany
Rzeszów, Podkarpackie Voivodeship 35-055, Poland