New drug targets eczema itch even when rash is mild
NCT ID NCT07006792
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether lebrikizumab can reduce itching and skin symptoms in people with moderate eczema who have a high itch burden. About 233 adults and teens will receive the drug for 24 weeks. The main goal is to see if at least 75% of skin symptoms improve or if itch scores drop by at least 4 points.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lebrikizumab (a drug injected under the skin)
- What this could lead to
- If it works, this could offer a new option for people with eczema who have severe itching even with limited skin involvement.
- What could go wrong
- This is an early-phase, open-label study with no placebo group, so results may be less reliable. It also only includes people with moderate eczema, so findings may not apply to severe cases.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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233 people
The number who actually took part.
- Started
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Jun 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
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AlergoAlpha - Barueri
Barueri, 06454-010, Brazil
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Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301, United States
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Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032, United States
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Biopharma Informatic, LLC
Houston, Texas, 77084, United States
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Brunswick Dermatology Center
Fredericton, E3B 1G9, Canada
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CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
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CIPREC
Buenos Aires, 1061, Argentina
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CMRC Headlands, LLC
San Juan, 00918, Puerto Rico
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CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012, Argentina
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California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
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Centre de Recherche Saint-Louis
Sherbrooke, J1G 1X9, Canada
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Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
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Centro de Investigaciones San Miguel
San Miguel, 1663, Argentina
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Centro de Pesquisas da Clínica IBIS
Salvador, 41820-020, Brazil
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DOM Centro de Reumatología
Buenos Aires, C1111, Argentina
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Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
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DeNova Research
Chicago, Illinois, 60602, United States
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Deluxe Health Center
Miami Lakes, Florida, 33014, United States
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Dermatology Affiliates Research Institute
Atlanta, Georgia, 30305, United States
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Dermatology Research Associates
Los Angeles, California, 90045, United States
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Dr. Samuel Sanchez PSC
Caguas, 00725, Puerto Rico
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Encore Medical Research
Hollywood, Florida, 33024, United States
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Equity Medical
New York, New York, 10023, United States
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Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104, United States
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Eternal Springtime Dermatology
Thunder Bay, P7C 4Y7, Canada
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Faculdade de Medicina do ABC
Santo André, 09060-870, Brazil
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Foxhall Research Center
Chevy Chase, Maryland, 20815, United States
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Fundación Respirar
Buenos Aires, C1426ABP, Argentina
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Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
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Health Clinical Research
Miami, Florida, 33176, United States
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Hickory Dermatology Research Center
Hickory, North Carolina, 28602, United States
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Hospital São Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
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IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
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INECO Neurociencias Oroño
Rosario, 2000, Argentina
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ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, 12243-280, Brazil
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Instituto de Investigaciones Clinicas Rosario
Rosario, S2000CVD, Argentina
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Instituto de Neumonologia Y Dermatologia
Buenos Aires, C1425BEA, Argentina
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Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
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Jordan Valley Dermatology & Research Center
South Jordan, Utah, 84095, United States
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Kanata Allergy Clinic
Ottawa, K2T 0N7, Canada
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Leading Edge Dermatology
Plantation, Florida, 33317, United States
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Life Arc Research Centers - Miami
Miami, Florida, 33126, United States
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Lovegrove Dermatology
London, N6A 5R9, Canada
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MCR Research
Miami, Florida, 33126, United States
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Maritime Dermatology
Halifax, B3K 5R3, Canada
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NorCal Clinical Research
Rocklin, California, 95765, United States
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North York Research Inc
Toronto, M2N 3A6, Canada
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ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville, Tennessee, 37072, United States
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PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba, 80230-130, Brazil
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Parra Dermatología
Mendoza, 5500, Argentina
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Prime Clinical Research - Mansfield
Mansfield, Texas, 76063, United States
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Psoriahue
Buenos Aires, C1425DKG, Argentina
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Renstar Medical Research
Ocala, Florida, 34470, United States
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Research Solutions of Arizona
Litchfield Park, Arizona, 85340, United States
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Reveal Research Institute - Frisco
Frisco, Texas, 75033, United States
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Revival Research Institute, LLC
Troy, Michigan, 48084, United States
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SKiN Centre for Dermatology
Peterborough, K9J 5K2, Canada
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Skin Care West
Nanaimo, V9V 1A3, Canada
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Solutions Through Advanced Research
Jacksonville, Florida, 32256, United States
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Southern Indiana Clinical Research Center
Columbus, Indiana, 47201, United States
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Southern Indiana Clinical Trials
New Albany, Indiana, 47150, United States
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Suncoast Research Associates
Doral, Florida, 33172, United States
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Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, 78235, United States
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Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama, 35203, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Skin scans may predict who responds to dupilumab for eczema
- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
- Scientists probe whether lebrikizumab rewires diseased skin at the molecular level
- Can a Lab-Made antibody calm severe eczema?
- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?