A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
NCT ID: NCT05372419
Last Updated: 2025-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2023-01-12
2025-02-17
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 250 mg Q2W
Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.
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 are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.
* Participants who are Fitzpatrick phototype IV-VI
* 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.
* Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.
* Contraceptive use - Male and/or female
* Male participants are not required to use any contraception except in compliance with specific local government study requirements.
* Female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. Women of non-child-bearing potential (non-WOCBP) may participate without any contraception requirements.
Exclusion Criteria
* Have a current infection or chronic infection with hepatitis B virus (HBV) at screening, that is, positive for hepatitis B surface antigen (HBsAg) 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 prior treatment with dupilumab
* Had prior treatment with tralokinumab
* Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.
* Treatment with any of the following agents within 4 weeks prior to the baseline:
* systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants);
* small molecules (for example, Janus Kinase (JAK) inhibitors);
* phototherapy and photochemotherapy for AD.
* History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
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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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
First OC Dermatology
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.
Fremont, 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
Cura Clinical Research
Palmdale, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, 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
Skin Care Research, Inc
Hollywood, Florida, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
Miami Dermatology and Laser Research
Miami, Florida, United States
Savin Medical Group, LLC
Miami Lakes, Florida, United States
PureSkin Dermatology
Orlando, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Allcutis Research, Inc.
Beverly, Massachusetts, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Revival Research Institute - Troy
Troy, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Skin Specialists, P.C
Omaha, Nebraska, United States
Sadick Research Group
New York, New York, United States
Wilmington Health Family Medicine
Wilmington, North Carolina, United States
Dermatology & Laser Center of Charleston
Charleston, South Carolina, United States
Arlington Research Center, Inc
Arlington, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Complete Dermatology
Sugar Land, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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References
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Alexis A, Moiin A, Waibel J, Wallace P, Cohen D, Laquer V, Kwong P, Atwater AR, Schuster C, Proper J, Silk M, Pierce E, Pillai S, Rueda MJ, Moore A; ADmirable Investigators. Efficacy and Safety of Lebrikizumab in Adult and Adolescent Patients with Skin of Color and Moderate-to-Severe Atopic Dermatitis: Results from the Phase IIIb, Open-Label ADmirable Study. Am J Clin Dermatol. 2025 Sep;26(5):803-817. doi: 10.1007/s40257-025-00970-8. Epub 2025 Jul 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
Other Identifiers
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J2T-MC-KGBP
Identifier Type: OTHER
Identifier Source: secondary_id
18500
Identifier Type: -
Identifier Source: org_study_id
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