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NCT07006792CompletedPhase 4

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

A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
233 (actual)
First submitted
28 May 2025
Start date
16 Jun 2025
Primary completion date
14 May 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT07006792

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 233
  • From 16 Jun 2025 to the primary completion date, 14 May 2026
  • 66 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Have an uncontrolled chronic disease that might require multiple intermittent uses of 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 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 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).

Other

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

Who the study is looking for

  • Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus 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) 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.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (66)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto de Neumonologia y Dermatologia
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Buenos AiresArgentinaUnknown status
Fundacion Respirar
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Buenos AiresArgentinaUnknown status
CIPREC
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Buenos AiresArgentinaUnknown status
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaUnknown status
Psoriahue
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Buenos AiresArgentinaUnknown status
CONEXA Investigacion Clinica S.A.
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Buenos AiresArgentinaUnknown status
DOM Centro de Reumatología
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Buenos AiresArgentinaUnknown status
Parra Dermatología
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MendozaArgentinaUnknown status
Instituto de Investigaciones Clinicas Rosario
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RosarioArgentinaUnknown status
INECO Neurociencias Oroño
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RosarioArgentinaUnknown status
Centro de Investigaciones San Miguel
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San MiguelArgentinaUnknown status
AlergoAlpha - Barueri
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BarueriBrazilUnknown status
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
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CuritibaBrazilUnknown status
Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
IBPClin - Instituto Brasil de Pesquisa Clínica
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Rio de JaneiroBrazilUnknown status
Centro de Pesquisas da Clínica IBIS
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SalvadorBrazilUnknown status
Faculdade de Medicina do ABC
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Santo AndréBrazilUnknown status
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
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São José dos CamposBrazilUnknown status
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilUnknown status
Brunswick Dermatology Center
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FrederictonCanadaUnknown status
Maritime Dermatology
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HalifaxCanadaUnknown status
Lovegrove Dermatology
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LondonCanadaUnknown status
Skin Care West
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NanaimoCanadaUnknown status
Kanata Allergy Clinic
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OttawaCanadaUnknown status
SKiN Centre for Dermatology
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PeterboroughCanadaUnknown status
Centre de Recherche Saint-Louis
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SherbrookeCanadaUnknown status
Eternal Springtime Dermatology
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Thunder BayCanadaUnknown status
North York Research Inc.
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TorontoCanadaUnknown status
Dr. Samuel Sanchez PSC
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CaguasPuerto RicoUnknown status
CMRC Headlands, LLC
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San JuanPuerto RicoUnknown status
Albuquerque Clinical Trials, Inc.
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AlbuquerqueUnited StatesUnknown status
Dermatology Affiliates Research Institute
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AtlantaUnited StatesUnknown status
Great Lakes Research Group, Inc.
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Bay CityUnited StatesUnknown status
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
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BirminghamUnited StatesUnknown status
Equity Medical Bowling Green
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Bowling GreenUnited StatesUnknown status
Foxhall Research Center
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Chevy ChaseUnited StatesUnknown status
DeNova Research
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ChicagoUnited StatesUnknown status
Southern Indiana Clinical Research Center
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ColumbusUnited StatesUnknown status
Suncoast Research Associates
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DoralUnited StatesUnknown status
California Dermatology & Clinical Research Institute
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EncinitasUnited StatesUnknown status
Reveal Research Institute - Frisco
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FriscoUnited StatesUnknown status
ObjectiveHealth - Goodlettsville Dermatology Research
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GoodlettsvilleUnited StatesUnknown status
Hickory Dermatology Research Center
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HickoryUnited StatesUnknown status
Encore Medical Research
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HollywoodUnited StatesUnknown status
Biopharma Informatic, LLC
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HoustonUnited StatesUnknown status
Dawes Fretzin Clinical Research Group, LLC
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IndianapolisUnited StatesUnknown status
Solutions Through Advanced Research
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JacksonvilleUnited StatesUnknown status
Research Solutions of Arizona
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Litchfield ParkUnited StatesUnknown status
Dermatology Research Associates
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Los AngelesUnited StatesUnknown status
Prime Clinical Research - Mansfield
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MansfieldUnited StatesUnknown status
Life Arc Research Centers - Miami
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MiamiUnited StatesUnknown status
MCR Research
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MiamiUnited StatesUnknown status
Health Clinical Research
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MiamiUnited StatesUnknown status
Deluxe Health Center
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Miami LakesUnited StatesUnknown status
Southern Indiana Clinical trials
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New AlbanyUnited StatesUnknown status
Equity Medical
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Allergy & Asthma Specialists, P.S.C.
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OwensboroUnited StatesUnknown status
Alliance Dermatology and Mohs Center
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PhoenixUnited StatesUnknown status
Leading Edge Dermatology
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PlantationUnited StatesUnknown status
NorCal Clinical Research
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RocklinUnited StatesUnknown status
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
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San AntonioUnited StatesUnknown status
Jordan Valley Dermatology & Research Center
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South JordanUnited StatesUnknown status
Revival Research Institute, LLC
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TroyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.