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RECRUITING

NCT07006792

PHASE4

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-06-16

Completion Date

2026-09

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

Lebrikizumab

Administered SC

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.

Locations (71)

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

Dermatologists of Central States, LLC

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

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

CMRC Headlands, LLC

San Juan, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)