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

Last updated: March 1, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Eczema (Atopic Dermatitis - Pediatric)

Eczema (Atopic Dermatitis)

Treatment

Lebrikizumab

Clinical Study ID

NCT05369403
18499
J2T-MC-KGBO
  • Ages > 12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants must have prior treatment with dupilumab meeting one of thefollowing conditions:

  • Participants who stopped dupilumab treatment due to non-response, partialresponse, loss of efficacy must have been previously treated with dupilumab (atlabeled dose level) for at least 4 months.

  • Participants who stopped dupilumab treatment due to intolerance or adverseevents (AEs) to the drug may enter the study with no required prior length ofdupilumab treatment.

  • Participants who stopped dupilumab treatment due to cost or loss of access todupilumab (for example, insurance coverage) may enter the study with norequired 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; ordetermination that topical treatments are otherwise medically inadvisable.

  • Adolescents body weight must be ≥40 kg at baseline.

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 and/or polymerase chainreaction 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 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 2weeks prior to baseline

  • Treatment with any of the following agents within 4 weeks prior to the baseline

  • systemic immunosuppressive or immunomodulating drugs (e.g., systemiccorticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine,methotrexate, and other immunosuppressants)

  • small molecules (e.g. JAK inhibitors)

  • phototherapy and photochemotherapy for AD

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: Lebrikizumab
Phase: 3
Study Start date:
December 19, 2022
Estimated Completion Date:
February 05, 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

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    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

  • UCSF Medical Center at Mission Bay

    San Francisco, California 94115
    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

  • UConn Health

    Farmington, Connecticut 06030-2840
    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

    Site Not Available

  • Total Vein and Skin, LLC

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Access Research Institute

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Doral Medical Research

    Doral, Florida 33166
    United States

    Site Not Available

  • Doral Research Center

    Doral, Florida 33166
    United States

    Site Not Available

  • Direct Helpers Medical Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Hollywood Dermatology

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Skin Care Research, Inc

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Olympian Clinical Research

    Largo, Florida 33770
    United States

    Site Not Available

  • Century Research LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • Miami Dermatology and Laser Research

    Miami, Florida 33173
    United States

    Site Not Available

  • Savin Medical Group, LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Tory Sullivan, MD PA

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Ziaderm Research, LLC.

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Olympian Clinical Research

    Tampa, Florida 33615
    United States

    Site Not Available

  • Research Institute of the southeast

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Research Institute of the southeast, LLC

    West Palm Beach, Florida 33401 2717
    United States

    Site Not Available

  • Skin Care Physicians of Georgia

    Macon, Georgia 31217
    United States

    Site Not Available

  • Marietta Dermatology Clinical Research

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Advanced Medical Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Dundee Dermatology

    West Dundee, Illinois 60118
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Dermatology Specialists Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Skin Sciences, PLLC

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Dermatology and Advanced Aesthetics

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Dr. Shondra Smith MD

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Best Clinical Trials

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • ActivMed Practices and Research

    Beverly, Massachusetts 01915
    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

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Site Not Available

  • Revival Research Institute - Troy

    Troy, Michigan 48084
    United States

    Site Not Available

  • MediSearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Skin Specialists, P.C

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • ActivMed Practices and Research

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Allcutis Research, Inc

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Allcutis Research, Inc.

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Windsor Dermatology, P.C.

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Schweiger Dermatology Group

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Rochester Skin Lymphoma Medical Group, PLLC

    Fairport, New York 14450
    United States

    Site Not Available

  • OptiSkin Medical

    New York, New York 10128
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Dermatologists of Greater Columbus

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Dermatology and Skin Surgery Center, PC

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Clinical Partners, LLC

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • International Clinical Research

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • International Clinical Research - Tennessee (IC Research)

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arlington Research Center, Inc

    Arlington, Texas 76011
    United States

    Site Not Available

  • Complete Dermatology

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99202
    United States

    Site Not Available

  • Spokane Dermatology

    Spokane, Washington 99204
    United States

    Site Not Available

  • Spokane Dermatology Clinic

    Spokane, Washington 99202
    United States

    Site Not Available

  • West Virginia Research Institute

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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