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

Last updated: June 10, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Allergies & Asthma

Skin Infections/disorders

Treatment

Lebrikizumab

Clinical Study ID

NCT05372419
18500
J2T-MC-KGBP
  • Ages > 12
  • All Genders

Study Summary

The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent.

  • Participants who are self-reported race other than White, including but not limitedto persons who self-identify as Black or African American, American Indian or AlaskaNative, 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; ordetermination 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 proceduresand questionnaires.

  • Contraceptive use - Male and/or female

  • Male participants are not required to use any contraception except incompliance 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 contraceptivemethod during the treatment period and for at least 18 weeks after the lastdose of study drug. Women of non-child-bearing potential (non-WOCBP) mayparticipate without any contraception requirements.

Exclusion

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) infection or positive HIV serology atscreening.

  • Have a current infection or chronic infection with hepatitis B virus (HBV) atscreening, that is, positive for hepatitis B surface antigen (HBsAg) and/orpolymerase 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 usesof 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, JAKinhibitors, 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, systemiccorticosteroids, 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 ofthe cervix of completely treated and resolved non-metastatic squamous or basal cellcarcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Lebrikizumab
Phase: 3
Study Start date:
January 12, 2023
Estimated Completion Date:
February 17, 2025

Connect with a study center

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • River Region Dermatology and Laser

    Montgomery, Alabama 36117
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Axon Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

  • Avance Clinical Trials Inc

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Avance Trials

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Wallace Medical Group, Inc.

    Los Angeles, California 90056
    United States

    Site Not Available

  • Cura Clinical Research

    Palmdale, California 93551
    United States

    Site Not Available

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California 95816
    United States

    Site Not Available

  • University of California Davis-Dermatology

    Sacramento, California 95816
    United States

    Active - Recruiting

  • San Francisco Research Institute

    San Francisco, California 94127
    United States

    Site Not Available

  • Synergy Dermatology

    San Francisco, California 94132
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Cura Clinical Research

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Progressive Clinical Research

    Vista, California 92083
    United States

    Site Not Available

  • UConn Health

    Farmington, Connecticut 06030-2840
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Skin Care Research, Inc

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Encore Medical Research of Boynton Beach

    Boynton Beach, Florida 33436
    United States

    Site Not Available

  • Total Vein and Skin LLC

    Boynton Beach, Florida 33437
    United States

    Active - Recruiting

  • Total Vein and Skin, LLC

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Accel Research Sites

    DeLand, Florida 32720
    United States

    Site Not Available

  • Accel Research Sites- Clinical Research Unit

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • D&H Doral Research Center LLC

    Doral, Florida 33122
    United States

    Site Not Available

  • Encore Medical Research of Boynton Beach

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Skin Care Research, Inc

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Miami Dermatology and Laser Research

    Miami, Florida 33173
    United States

    Site Not Available

  • Skin and Cancer Associates, LLP

    Miami, Florida 33137
    United States

    Active - Recruiting

  • Savin Medical Group, LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • PureSkin Dermatology

    Orlando, Florida 32819
    United States

    Site Not Available

  • University Clinical Research-Deland, LLC

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • ForCare Clinical Research

    Tampa, Florida 33613-1244
    United States

    Site Not Available

  • Skin Care Physicians of Georgia

    Macon, Georgia 31217
    United States

    Site Not Available

  • Advanced Medical Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Skin Sciences, PLLC

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Kindred Hair and Skin

    Columbia, Maryland 21104
    United States

    Site Not Available

  • Allcutis Research, Inc.

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Revival Research Institute - Troy

    Troy, Michigan 48084
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Skin Specialists, P.C

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • ALLCUTIS Research

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • Weil Cornell Medicine Dermatology Research

    New York, New York 10075
    United States

    Site Not Available

  • Wilmington Health Family Medicine

    Wilmington, North Carolina 28411
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Dermatology & Laser Center of Charleston

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Arlington Research Center, Inc

    Arlington, Texas 76011
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Complete Dermatology

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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