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New drug targets eczema itch even when rash is mild

NCT ID NCT07006792

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

233 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

12 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102, United States

  • AlergoAlpha - Barueri

    Barueri, 06454-010, Brazil

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

    Owensboro, Kentucky, 42301, United States

  • Alliance Dermatology and Mohs Center

    Phoenix, Arizona, 85032, United States

  • Biopharma Informatic, LLC

    Houston, Texas, 77084, United States

  • Brunswick Dermatology Center

    Fredericton, E3B 1G9, Canada

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010, Brazil

  • CIPREC

    Buenos Aires, 1061, Argentina

  • CMRC Headlands, LLC

    San Juan, 00918, Puerto Rico

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012, Argentina

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024, United States

  • Centre de Recherche Saint-Louis

    Sherbrooke, J1G 1X9, Canada

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI, Argentina

  • Centro de Investigaciones San Miguel

    San Miguel, 1663, Argentina

  • Centro de Pesquisas da Clínica IBIS

    Salvador, 41820-020, Brazil

  • DOM Centro de Reumatología

    Buenos Aires, C1111, Argentina

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • DeNova Research

    Chicago, Illinois, 60602, United States

  • Deluxe Health Center

    Miami Lakes, Florida, 33014, United States

  • Dermatology Affiliates Research Institute

    Atlanta, Georgia, 30305, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dr. Samuel Sanchez PSC

    Caguas, 00725, Puerto Rico

  • Encore Medical Research

    Hollywood, Florida, 33024, United States

  • Equity Medical

    New York, New York, 10023, United States

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104, United States

  • Eternal Springtime Dermatology

    Thunder Bay, P7C 4Y7, Canada

  • Faculdade de Medicina do ABC

    Santo André, 09060-870, Brazil

  • Foxhall Research Center

    Chevy Chase, Maryland, 20815, United States

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706, United States

  • Health Clinical Research

    Miami, Florida, 33176, United States

  • Hickory Dermatology Research Center

    Hickory, North Carolina, 28602, United States

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180, Brazil

  • INECO Neurociencias Oroño

    Rosario, 2000, Argentina

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, 12243-280, Brazil

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, S2000CVD, Argentina

  • Instituto de Neumonologia Y Dermatologia

    Buenos Aires, C1425BEA, Argentina

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170, Brazil

  • Jordan Valley Dermatology & Research Center

    South Jordan, Utah, 84095, United States

  • Kanata Allergy Clinic

    Ottawa, K2T 0N7, Canada

  • Leading Edge Dermatology

    Plantation, Florida, 33317, United States

  • Life Arc Research Centers - Miami

    Miami, Florida, 33126, United States

  • Lovegrove Dermatology

    London, N6A 5R9, Canada

  • MCR Research

    Miami, Florida, 33126, United States

  • Maritime Dermatology

    Halifax, B3K 5R3, Canada

  • NorCal Clinical Research

    Rocklin, California, 95765, United States

  • North York Research Inc

    Toronto, M2N 3A6, Canada

  • ObjectiveHealth - Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072, United States

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

    Curitiba, 80230-130, Brazil

  • Parra Dermatología

    Mendoza, 5500, Argentina

  • Prime Clinical Research - Mansfield

    Mansfield, Texas, 76063, United States

  • Psoriahue

    Buenos Aires, C1425DKG, Argentina

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340, United States

  • Reveal Research Institute - Frisco

    Frisco, Texas, 75033, United States

  • Revival Research Institute, LLC

    Troy, Michigan, 48084, United States

  • SKiN Centre for Dermatology

    Peterborough, K9J 5K2, Canada

  • Skin Care West

    Nanaimo, V9V 1A3, Canada

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256, United States

  • Southern Indiana Clinical Research Center

    Columbus, Indiana, 47201, United States

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • Suncoast Research Associates

    Doral, Florida, 33172, United States

  • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue

    San Antonio, Texas, 78235, United States

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

    Birmingham, Alabama, 35203, United States

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Other studies related to the condition(s) this trial covers.