A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.

Key facts

Study ID

NCT05369403

Run by

Eli Lilly and Company

People needed

86

Starts

2022-12-19

Expected to finish

2025-02-05

Last updated by the study team

2026-02-25

Who can join

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

You may qualify if…

• All participants must have prior treatment with dupilumab meeting one of the following conditions:
• Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
• Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
• Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
• Participants who have chronic AD that has been present for ≥1 year before screening.
• Have EASI ≥16 at baseline
• Have IGA score ≥3 (Scale of 0 to 4) at baseline
• Have ≥10% body surface area (BSA) of AD involvement at baseline
• Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
• Adolescents body weight must be ≥40 kg at baseline.

You may not qualify if…

• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
• Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
• Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
• Have uncontrolled asthma that
• might require bursts of oral or systemic corticosteroids, or
• required the following due to ≥1 exacerbations within 12 months before baseline
• systemic (oral and/or parenteral) corticosteroid treatment, or
• hospitalization for >24 hours.
• Have known liver cirrhosis and/or chronic hepatitis of any etiology.
• Had Dupilumab treatment within 4 weeks prior to baseline
• Had prior treatment with tralokinumab.
• Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
• Treatment with any of the following agents within 4 weeks prior to the baseline
• systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
• small molecules (e.g. JAK inhibitors)
• phototherapy and photochemotherapy for AD

Where it is running

• River Region Dermatology and Laser — Montgomery, Alabama, United States
• Medical Dermatology Specialists — Phoenix, Arizona, United States
• First OC Dermatology — Fountain Valley, California, United States
• Axon Clinical Research — Inglewood, California, United States
• Avance Clinical Trials Inc — Laguna Niguel, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Wallace Medical Group, Inc. — Los Angeles, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Cura Clinical Research — Sherman Oaks, California, United States
• UConn Health — Farmington, Connecticut, United States
• Encore Medical Research of Boynton Beach — Boynton Beach, Florida, United States
• Total Vein and Skin LLC — Boynton Beach, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Hollywood Dermatology — Hollywood, Florida, United States
• Miami Dermatology and Laser Research — Miami, Florida, United States
• Ziaderm Research, LLC. — North Miami Beach, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Skin Care Physicians of Georgia — Macon, Georgia, United States
• Advanced Medical Research — Sandy Springs, Georgia, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dermatology and Advanced Aesthetics — Lake Charles, Louisiana, United States
• Dermatology and Skin Cancer Specialists, LLC — Rockville, Maryland, United States
• Allcutis Research, Inc. — Beverly, Massachusetts, United States
• Oakland Hills Dermatology — Auburn Hills, Michigan, United States

Full record on ClinicalTrials.gov

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