A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden

Last updated: July 15, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

4

Condition

Dermatitis, Atopic

Eczema (Atopic Dermatitis - Pediatric)

Skin Infections/disorders

Treatment

Lebrikizumab

Clinical Study ID

NCT07006792
27407
J2T-MC-KGCE
  • Ages > 12
  • All Genders

Study Summary

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.

Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have chronic atopic dermatitis (AD) (according to American Academy of DermatologyConsensus Criteria) that has been present for ≥1 year before screening visit.

  • Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.

  • Have pruritus numeric rating scale (NRS) ≥6 at baseline.

  • Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.

  • Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) atscreening and baseline.

  • Based on investigator judgement, have a history of inadequate response to treatmentwith topical medications, or determination that topical treatments are otherwisemedically inadvisable.

  • For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) atbaseline.

Exclusion

Exclusion Criteria:

  • Have an uncontrolled chronic disease that might require multiple intermittent usesof oral corticosteroids at screening (as defined by the investigator).

  • Have known liver cirrhosis and/or chronic hepatitis of any etiology.

  • 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 nonmetastatic squamous or basal cellcarcinoma of the skin with no evidence of recurrence in the past 12 weeks.

  • Are diagnosed with active endoparasitic infections or at high risk of theseinfections.

  • Have a known or suspected history of immunosuppression, including history ofinvasive opportunistic infections despite infection resolution; or unusuallyfrequent, recurrent, or prolonged infections, per the investigator's judgment.

  • Have presence of skin comorbidities that may interfere with study assessments.

  • Have a severe concomitant illness(es) that in the investigator's judgment wouldadversely affect the participant's participation in the study.

  • Have had any of the following types of infection within 3 months of screening ordevelop any of these infections during screening:

  • Serious (requiring hospitalization, and/or intravenous or equivalent oralantibiotic treatment).

  • Opportunistic - Note: Herpes zoster is considered active and ongoing until allvesicles are dry and crusted over.

  • Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).

  • Recurring (including, but not limited to, recurring cellulitis and chronicosteomyelitis).

  • Have an active or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before thebaseline visit or superficial skin infections within 1 week before the baselinevisit.

  • Have had any prior treatment with a biologic therapy for AD.

  • Have had treatment with any of the following agents within 4 weeks prior to thebaseline visit:

  • systemic immunosuppressive or immunomodulating drugs (for example, systemiccorticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,

  • azathioprine, methotrexate, and other immunosuppressants)

  • small molecules (for example, Janus kinase inhibitors [topical or systemic]),or

  • phototherapy and photochemotherapy for AD.

  • Treatment with B-cell-depleting biologics, including rituximab, within 6 monthsprior to baseline.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Lebrikizumab
Phase: 4
Study Start date:
June 16, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Instituto de Neumonologia Y Dermatologia

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425BEA
    Argentina

    Site Not Available

  • Psoriahue

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
    Argentina

    Site Not Available

  • Fundación Respirar

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
    Argentina

    Site Not Available

  • Centro de Investigaciones San Miguel

    San Miguel, Buenos Aires 1663
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe S2000CVD
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, 1061
    Argentina

    Site Not Available

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • DOM Centro de Reumatología

    Ciudad Autónoma de Buenos Aires, C1111
    Argentina

    Site Not Available

  • Parra Dermatología

    Mendoza, 5500
    Argentina

    Site Not Available

  • Centro de Pesquisas da Clínica IBIS

    Salvador, Bahia 41820-020
    Brazil

    Site Not Available

  • PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR

    Curitiba, Paraná 80230-130
    Brazil

    Site Not Available

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90050-170
    Brazil

    Site Not Available

  • AlergoAlpha - Barueri

    Barueri, São Paulo 06454-010
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo Andre, São Paulo 09060-870
    Brazil

    Site Not Available

  • Clinica de Alergia Martti Antila

    Sorocaba, São Paulo 18040-425
    Brazil

    Site Not Available

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo 12243-280
    Brazil

    Site Not Available

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Skin Physicians Dermatology

    Edmonton, Alberta T6W 4V4
    Canada

    Site Not Available

  • Skin Care West

    Nanaimo, British Columbia V9V 1A3
    Canada

    Site Not Available

  • Brunswick Dermatology Center

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Maritime Dermatology

    Halifax, Nova Scotia B3K 5R3
    Canada

    Site Not Available

  • Lovegrove Dermatology

    London, Ontario N6A 5R9
    Canada

    Site Not Available

  • Kanata Allergy Clinic

    Ottawa, Ontario K2T 0N7
    Canada

    Site Not Available

  • SKiN Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Oak Ridges Aesthetics Centre

    Richmond Hill, Ontario L4E 4L6
    Canada

    Site Not Available

  • Eternal Springtime Dermatology

    Thunder Bay, Ontario P7C 4Y7
    Canada

    Site Not Available

  • North York Research Inc

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Sherbrooke, Quebec J1G 1X9
    Canada

    Site Not Available

  • Dr. Samuel Sanchez PSC

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

    Birmingham, Alabama 35203
    United States

    Site Not Available

  • Research Solutions of Arizona

    Litchfield Park, Arizona 85340
    United States

    Site Not Available

  • Alliance Dermatology and Mohs Center

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • First OC Dermatology Research Inc

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • NorCal Clinical Research

    Rocklin, California 95765
    United States

    Site Not Available

  • Suncoast Research Associates

    Doral, Florida 33172
    United States

    Site Not Available

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Health Clinical Research

    Miami, Florida 33176
    United States

    Site Not Available

  • Life Arc Research Centers - Miami

    Miami, Florida 33126
    United States

    Active - Recruiting

  • MCR Research

    Miami, Florida 33126
    United States

    Site Not Available

  • Deluxe Health Center

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Leading Edge Dermatology

    Plantation, Florida 33317
    United States

    Active - Recruiting

  • Research Institute of the Southeast

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Dermatology Affiliates Research Institute

    Atlanta, Georgia 30305
    United States

    Site Not Available

  • ObjectiveHealth - Dermatology Affiliates Research Institute

    Atlanta, Georgia 30305
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Evans, Georgia 30809
    United States

    Site Not Available

  • DeNova Research

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Southern Indiana Clinical Research Center

    Columbus, Indiana 47201
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky 42104
    United States

    Site Not Available

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Foxhall Research Center

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Equity Medical

    New York, New York 10023
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Hickory Dermatology Research Center

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • ObjectiveHealth - Goodlettsville Dermatology Research

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • John Peter Smith Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Reveal Research Institute - Frisco

    Frisco, Texas 75033
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77084
    United States

    Active - Recruiting

  • Prime Clinical Research - Mansfield

    Mansfield, Texas 76063
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Jordan Valley Dermatology & Research Center

    South Jordan, Utah 84095
    United States

    Site Not Available

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