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
Vilnius, LT-08406, Lithuania
Iwonicz-Zdrój, Podkarpackie Voivodeship 38-440, Poland
Szczecin, West Pomeranian Voivodeship 71-434, Poland
SANT BOI de Llobrega, Barcelona 08830, Spain