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A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Not Recruiting
Trial ID: NCT03443024
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
Stanford Investigator(s)
Justin M Ko, MD, MBA
Clinical Professor, Dermatology
Eligibility
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.
Intervention(s):
biological: Lebrikizumab
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305