Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) 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 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

Key facts

Study ID

NCT04178967

Run by

Eli Lilly and Company

People needed

445

Starts

2019-10-29

Expected to finish

2022-04-28

Last updated by the study team

2023-05-24

Who can join

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

You may qualify if…

• Male or female adults and adolescents (≥12 years and ≥40 kg)
• Chronic atopic dermatitis (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 atopic dermatitis involvement at the baseline visit
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

You may not qualify if…

• Prior treatment with dupilumab or tralokinumab
• Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
• 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 the following prior to the baseline visit:
• An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
• Cell-depleting biologics, including to rituximab, within 6 months of baseline
• Other biologics within 5 half-lives (if known) or 16 weeks of baseline, 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, e.g., co-morbid severe uncontrolled asthma
• Evidence of active acute or chronic hepatitis
• History of human immunodeficiency virus (HIV) infection or positive HIV serology
• 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

• Northwest Arkansas Clinical Trials Center — Rogers, Arkansas, United States
• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
• Woodward Centre — Fresno, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• LA Universal Research Center, INC — Los Angeles, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• San Luis Dermatology & Laser Clinic — San Luis Obispo, California, United States
• Clinical Physiology Associates, Clinical Study Center — Fort Myers, Florida, United States
• Direct Helpers Medical Center — Hialeah, Florida, United States
• The Community Research of South Florida — Hialeah, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc — Albany, Georgia, United States
• Marietta Dermatology Clinical Research — Marietta, Georgia, United States
• Advanced Medical Research — Sandy Springs, Georgia, United States
• Arlington Dermatology — Rolling Meadows, Illinois, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• Kansas City Dermatology, PA — Overland Park, Kansas, United States
• Meridian Clinical Research — Baton Rouge, Louisiana, United States
• ActivMed Practices and Research — Beverly, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• Associated Skin Care Specialists — Fridley, Minnesota, United States
• Investigate MD — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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