Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04250337

Run by

Eli Lilly and Company

People needed

228

Starts

2020-02-03

Expected to finish

2021-09-16

Last updated by the study team

2022-05-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg).
• Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
• Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
• Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
• ≥10% body surface area (BSA) of AD involvement at the baseline visit.
• History of inadequate response to treatment with topical medications.

You may not qualify if…

• Participation in a prior lebrikizumab clinical study.
• Treatment with the following prior to the baseline visit:
• An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
• Dupilumab within 8 weeks.
• B-cell-depleting biologics, including to rituximab, within 6 months.
• Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
• Uncontrolled chronic disease that might require bursts of oral corticosteroids.
• Evidence of active acute or chronic hepatitis
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• 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.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Where it is running

• Orange County Research Institute — Anaheim, California, United States
• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• Wallace Medical Group, Inc. — Beverly Hills, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
• California Allergy and Asthma Medical Group + Research Center — Los Angeles, California, United States
• Keck School of Medicine University of Southern California — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• LA Universal Research Center, INC — Los Angeles, California, United States
• ACRC Studies — San Diego, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• Southern California Dermatology, Inc. — Santa Ana, California, United States
• Foxhall Dermatology — Washington D.C., District of Columbia, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• Direct Helpers Medical Center — Hialeah, Florida, United States
• The Community Research of South Florida — Hialeah, Florida, United States
• GSI Clinical Research, LLC — Margate, Florida, United States
• Vitae Research Center, LLC — Miami, Florida, United States
• Well Pharma Medical Research Corp. — Miami, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Advanced Medical Research — Sandy Springs, Georgia, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Dermatology and Skin Cancer Specialists — Rockville, Maryland, United States
• Investigate MD — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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