A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03443024

Run by

Eli Lilly and Company

People needed

280

Starts

2018-01-30

Expected to finish

2019-05-23

Last updated by the study team

2021-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dermatology Trial Associates — Bryant, Arkansas, United States
• Northwest Arkansas Clinical Trials Center — Rogers, Arkansas, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• University of Southern California — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Stanford Medicine Outpatient Center-Medical Dermatology Clinic — Redwood City, California, United States
• Center for Dermatology and Laser Surgery — Sacramento, California, United States
• UCSD Dermatology — San Diego, California, United States
• TCR Medical Corporation — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Total Vein and Skin — Boynton Beach, Florida, United States
• Florida Academic Centers Research and Education, LLC — Coral Gables, Florida, United States
• Olympian Clinical Research — Largo, Florida, United States
• Tory Sullivan, MD PA — North Miami Beach, Florida, United States
• International Clinical Research - US, LLC — Sanford, Florida, United States
• Integrated Clinical Research, LLC — West Palm Beach, Florida, United States
• Marietta Dermatology Clinical Research, Inc. — Marietta, Georgia, United States
• Advanced Medical Research, PC — Sandy Springs, Georgia, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Kansas City Dermatology, PA — Overland Park, Kansas, United States
• Skin Sciences, PLLC — Louisville, Kentucky, United States
• Clear Dermatology & Aesthetics Center — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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