A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Trial ID or NCT#
NCT03443024
Status
NOT RECRUITING
Purpose
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * Male or female, 18 years or older.* Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .* Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.* Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.* ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
Exclusion Criteria:
- * Treatment with any of the following agents within 4 weeks prior to the baseline visit:* Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)* Phototherapy and photochemotherapy (PUVA) for AD.* Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.* Treatment with:* An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.* Dupilumab within 3 months prior to baseline visit.* Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.* Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).* Use of prescription moisturizers within 7 days of the baseline visit.
Investigator(s)
Justin M Ko, MD, MBA
Dermatologist,
Melanoma specialist,
Cutaneous oncology specialist,
Hair loss specialist,
Psoriasis specialist
Clinical Professor, Dermatology
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