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
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (66)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Neumonologia y Dermatologia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CIPREC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Psoriahue Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CONEXA Investigacion Clinica S.A. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| DOM Centro de Reumatología Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Parra Dermatología Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro de Investigaciones San Miguel Coordinator of this site? Confirm its status | San Miguel | Argentina | Unknown status |
| AlergoAlpha - Barueri Coordinator of this site? Confirm its status | Barueri | Brazil | Unknown status |
| PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Lucas da PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| IBPClin - Instituto Brasil de Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Centro de Pesquisas da Clínica IBIS Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Faculdade de Medicina do ABC Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| ISPEM - Instituto São José dos Campos em Pesquisas Médicas Coordinator of this site? Confirm its status | São José dos Campos | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Brunswick Dermatology Center Coordinator of this site? Confirm its status | Fredericton | Canada | Unknown status |
| Maritime Dermatology Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Lovegrove Dermatology Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Skin Care West Coordinator of this site? Confirm its status | Nanaimo | Canada | Unknown status |
| Kanata Allergy Clinic Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| SKiN Centre for Dermatology Coordinator of this site? Confirm its status | Peterborough | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Eternal Springtime Dermatology Coordinator of this site? Confirm its status | Thunder Bay | Canada | Unknown status |
| North York Research Inc. Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Dr. Samuel Sanchez PSC Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| CMRC Headlands, LLC Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Albuquerque Clinical Trials, Inc. Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Dermatology Affiliates Research Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Great Lakes Research Group, Inc. Coordinator of this site? Confirm its status | Bay City | United States | Unknown status |
| Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Equity Medical Bowling Green Coordinator of this site? Confirm its status | Bowling Green | United States | Unknown status |
| Foxhall Research Center Coordinator of this site? Confirm its status | Chevy Chase | United States | Unknown status |
| DeNova Research Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Southern Indiana Clinical Research Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Suncoast Research Associates Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| California Dermatology & Clinical Research Institute Coordinator of this site? Confirm its status | Encinitas | United States | Unknown status |
| Reveal Research Institute - Frisco Coordinator of this site? Confirm its status | Frisco | United States | Unknown status |
| ObjectiveHealth - Goodlettsville Dermatology Research Coordinator of this site? Confirm its status | Goodlettsville | United States | Unknown status |
| Hickory Dermatology Research Center Coordinator of this site? Confirm its status | Hickory | United States | Unknown status |
| Encore Medical Research Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Dawes Fretzin Clinical Research Group, LLC Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Solutions Through Advanced Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Research Solutions of Arizona Coordinator of this site? Confirm its status | Litchfield Park | United States | Unknown status |
| Dermatology Research Associates Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Prime Clinical Research - Mansfield Coordinator of this site? Confirm its status | Mansfield | United States | Unknown status |
| Life Arc Research Centers - Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| MCR Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Health Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Deluxe Health Center Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Southern Indiana Clinical trials Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| Equity Medical Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Allergy & Asthma Specialists, P.S.C. Coordinator of this site? Confirm its status | Owensboro | United States | Unknown status |
| Alliance Dermatology and Mohs Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Leading Edge Dermatology Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| NorCal Clinical Research Coordinator of this site? Confirm its status | Rocklin | United States | Unknown status |
| Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Jordan Valley Dermatology & Research Center Coordinator of this site? Confirm its status | South Jordan | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.