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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.
12 Years to N/A
1. Male or female adults and adolescents (≥12 years and ≥40 kg).
2. Chronic atopic dermatitis (according to American Academy of Dermatology Consensus
Criteria) that has been present for ≥1 year before the screening visit
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit.
5. ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
6. History of inadequate response to treatment with topical medications; or determination
that topical treatments are otherwise medically inadvisable.
1. Prior treatment with dupilumab or tralokinumab.
2. Treatment with the following prior to the baseline visit:
1. An investigational drug within 8 weeks or within 5 half-lives (if known) of
baseline, whichever is longer.
2. Cell-depleting biologics, including to rituximab, within 6 months of baseline.
3. Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever
3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
planned during the study.
4. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g.,
co-morbid severe uncontrolled asthma.
5. Evidence of active acute or chronic hepatitis
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology.
7. 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.
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study.
Study Director: Kate Doherty
Please refer to this study by its ClinicalTrials.gov identifier: NCT04146363
Encinitas, California 92024
Mission Viejo, California 92691