A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
NCT ID: NCT07006792
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2025-06-16
2026-09-30
Brief Summary
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Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.
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
Lebrikizumab administered subcutaneously (SC).
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
* 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) at screening and baseline.
* Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.
* For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.
Exclusion Criteria
* 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 of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
* Are diagnosed with active endoparasitic infections or at high risk of these infections.
* Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, 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 would adversely affect the participant's participation in the study.
* Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening:
* Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment).
* Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles 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 chronic osteomyelitis).
* Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit.
* 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 the baseline visit:
* systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, 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 months prior to baseline.
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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama, United States
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
NorCal Clinical Research
Rocklin, California, United States
Suncoast Research Associates
Doral, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
Life Arc Research Centers - Miami
Miami, Florida, United States
MCR Research
Miami, Florida, United States
Health Clinical Research
Miami, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Leading Edge Dermatology
Plantation, Florida, United States
Research Institute of the Southeast
West Palm Beach, Florida, United States
Dermatology Affiliates Research Institute
Atlanta, Georgia, United States
DeNova Research
Chicago, Illinois, United States
Southern Indiana Clinical Research Center
Columbus, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Foxhall Research Center
Chevy Chase, Maryland, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Equity Medical
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Hickory Dermatology Research Center
Hickory, North Carolina, United States
Wright State Physicians
Fairborn, Ohio, United States
ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Reveal Research Institute - Frisco
Frisco, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Prime Clinical Research - Mansfield
Mansfield, Texas, United States
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, United States
Jordan Valley Dermatology & Research Center
South Jordan, Utah, United States
CONEXA Investigacion Clinica S.A.
Buenos Aires, , Argentina
CIPREC
Buenos Aires, , Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
DOM Centro de Reumatología
Buenos Aires, , Argentina
Instituto de Neumonologia Y Dermatologia
Buenos Aires, , Argentina
Psoriahue
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
Parra Dermatología
Mendoza, , Argentina
INECO Neurociencias Oroño
Rosario, , Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, , Argentina
Centro de Investigaciones San Miguel
San Miguel, , Argentina
AlergoAlpha - Barueri
Barueri, , Brazil
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
Centro de Pesquisas da Clínica IBIS
Salvador, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, , Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, , Brazil
Dermatology Research Institute
Calgary, , Canada
Skin Physicians Dermatology
Edmonton, , Canada
Brunswick Dermatology Center
Fredericton, , Canada
Maritime Dermatology
Halifax, , Canada
Lovegrove Dermatology
London, , Canada
Skin Care West
Nanaimo, , Canada
Kanata Allergy Clinic
Ottawa, , Canada
SKiN Centre for Dermatology
Peterborough, , Canada
Oak Ridges Aesthetics Centre
Richmond Hill, , Canada
Centre de Recherche Saint-Louis
Sherbrooke, , Canada
Eternal Springtime Dermatology
Thunder Bay, , Canada
North York Research Inc
Toronto, , Canada
Dr. Samuel Sanchez PSC
Caguas, , Puerto Rico
Caribbean Medical Research Center
San Juan, , Puerto Rico
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Other Identifiers
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J2T-MC-KGCE
Identifier Type: OTHER
Identifier Source: secondary_id
27407
Identifier Type: -
Identifier Source: org_study_id