A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
NCT ID: NCT05369403
Last Updated: 2025-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
86 participants
INTERVENTIONAL
2022-12-19
2025-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lebrikizumab
Participants will receive Lebrikizumab by subcutaneous (SC) injection.
Lebrikizumab
Administered SC
Interventions
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Lebrikizumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
The Derm Institute of West Michigan
Caledonia, Michigan, United States
Revival Research Institute - Troy
Troy, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Allcutis Research, Inc
Portsmouth, New Hampshire, United States
Windsor Dermatology, P.C.
East Windsor, New Jersey, United States
Sadick Research Group
New York, New York, United States
OptiSkin Medical
New York, New York, United States
Dermatologists of Greater Columbus
Bexley, Ohio, United States
Dermatology and Skin Surgery Center, PC
Exton, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Complete Dermatology
Sugar Land, Texas, United States
Spokane Dermatology Clinic
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Other Identifiers
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J2T-MC-KGBO
Identifier Type: OTHER
Identifier Source: secondary_id
18499
Identifier Type: -
Identifier Source: org_study_id
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