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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.
12 Years to N/A
1. Male or female adult and adolescents (≥12 years to 17 years, and weighing ≥40 kg).
2. Chronic AD (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 AD 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. Participation in a prior lebrikizumab clinical study.
2. Treatment with the following prior to the baseline visit:
1. An investigational drug within 8 weeks or within 5 half-lives (if known),
whichever is longer.
2. Dupilumab within 8 weeks.
3. Cell-depleting biologics, including to rituximab, within 6 months.
4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
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.
5. Evidence of active acute or chronic hepatitis
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
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: NCT04250337
Friedrichshafen, Baden-Wuerttemberg 88045