Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

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

NCT04146363

Run by

Eli Lilly and Company

People needed

424

Starts

2019-09-24

Expected to finish

2022-05-03

Last updated by the study team

2022-11-30

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

• Wallace Medical Group, Inc. — Beverly Hills, California, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Belle Aimee Skincare Clinic — Fountain Valley, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• ACRC Studies — San Diego, California, United States
• Central Connecticut Dermatology — Cromwell, Connecticut, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Community Research Foundation Inc — Miami, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• IACT Health - VHC — Columbus, Georgia, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Skin Sciences, PLLC — Louisville, Kentucky, United States
• Beacon Clinical Research, LLC — Quincy, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St Joseph Dermatology and Vein Clinic — Saint Joseph, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• JDR Dermatology Research — Las Vegas, Nevada, United States
• ALLCUTIS Research — Portsmouth, New Hampshire, United States
• Icahn Sch of Med at Mt. Sinai — New York, New York, United States
• Sadick Research Group — New York, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Clinical Research Institute — Medford, Oregon, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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