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Recruiting Phase 4 NCT07006792

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

Phase 4 – monitoring after market approval
Conditions: Atopic Dermatitis

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Lebrikizumab
DRUG
Locations 66
Argentina (11)
CONEXA Investigacion Clinica S.A.
Buenos Aires
ACTIVE_NOT_RECRUITING
CIPREC
Buenos Aires
ACTIVE_NOT_RECRUITING
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
ACTIVE_NOT_RECRUITING
DOM Centro de Reumatología
Buenos Aires
ACTIVE_NOT_RECRUITING
Instituto de Neumonologia Y Dermatologia
Buenos Aires
ACTIVE_NOT_RECRUITING
Psoriahue
Buenos Aires
ACTIVE_NOT_RECRUITING
Fundación Respirar
Buenos Aires
ACTIVE_NOT_RECRUITING
Parra Dermatología
Mendoza
ACTIVE_NOT_RECRUITING
INECO Neurociencias Oroño
Rosario
ACTIVE_NOT_RECRUITING
Instituto de Investigaciones Clinicas Rosario
Rosario
ACTIVE_NOT_RECRUITING
Centro de Investigaciones San Miguel
San Miguel
ACTIVE_NOT_RECRUITING
Brazil (9)
AlergoAlpha - Barueri
Barueri
ACTIVE_NOT_RECRUITING
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba
ACTIVE_NOT_RECRUITING
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
ACTIVE_NOT_RECRUITING
Hospital São Lucas da PUCRS
Porto Alegre
ACTIVE_NOT_RECRUITING
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro
ACTIVE_NOT_RECRUITING
Centro de Pesquisas da Clínica IBIS
Salvador
ACTIVE_NOT_RECRUITING
Faculdade de Medicina do ABC
Santo André
ACTIVE_NOT_RECRUITING
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos
ACTIVE_NOT_RECRUITING
CEPIC - Centro Paulista de Investigação Clínica
São Paulo
ACTIVE_NOT_RECRUITING
Canada (9)
Brunswick Dermatology Center
Fredericton
ACTIVE_NOT_RECRUITING
Maritime Dermatology
Halifax
COMPLETED
Lovegrove Dermatology
London
ACTIVE_NOT_RECRUITING
Skin Care West
Nanaimo
ACTIVE_NOT_RECRUITING
Kanata Allergy Clinic
Ottawa
ACTIVE_NOT_RECRUITING
SKiN Centre for Dermatology
Peterborough
COMPLETED
Centre de Recherche Saint-Louis
Sherbrooke
ACTIVE_NOT_RECRUITING
Eternal Springtime Dermatology
Thunder Bay
ACTIVE_NOT_RECRUITING
North York Research Inc
Toronto
ACTIVE_NOT_RECRUITING
Puerto Rico (2)
Dr. Samuel Sanchez PSC
Caguas
ACTIVE_NOT_RECRUITING
CMRC Headlands, LLC
San Juan
ACTIVE_NOT_RECRUITING
United States (35)
Albuquerque Clinical Trials, Inc.
Albuquerque , New Mexico
ACTIVE_NOT_RECRUITING
Dermatology Affiliates Research Institute
Atlanta , Georgia
COMPLETED
Great Lakes Research Group, Inc.
Bay City , Michigan
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham , Alabama
ACTIVE_NOT_RECRUITING
Equity Medical - Bowling Green
Bowling Green , Kentucky
ACTIVE_NOT_RECRUITING
Foxhall Research Center
Chevy Chase , Maryland
COMPLETED
DeNova Research
Chicago , Illinois
ACTIVE_NOT_RECRUITING
Southern Indiana Clinical Research Center
Columbus , Indiana
COMPLETED
Suncoast Research Associates
Doral , Florida
COMPLETED
California Dermatology & Clinical Research Institute
Encinitas , California
Reveal Research Institute - Frisco
Frisco , Texas
ACTIVE_NOT_RECRUITING
ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville , Tennessee
COMPLETED
Hickory Dermatology Research Center
Hickory , North Carolina
COMPLETED
Encore Medical Research
Hollywood , Florida
ACTIVE_NOT_RECRUITING
Biopharma Informatic, LLC
Houston , Texas
ACTIVE_NOT_RECRUITING
Dawes Fretzin Clinical Research Group, LLC
Indianapolis , Indiana
ACTIVE_NOT_RECRUITING
Solutions Through Advanced Research
Jacksonville , Florida
ACTIVE_NOT_RECRUITING
Research Solutions of Arizona
Litchfield Park , Arizona
Dermatology Research Associates
Los Angeles , California
ACTIVE_NOT_RECRUITING
Prime Clinical Research - Mansfield
Mansfield , Texas
ACTIVE_NOT_RECRUITING
Life Arc Research Centers - Miami
Miami , Florida
COMPLETED
MCR Research
Miami , Florida
ACTIVE_NOT_RECRUITING
Health Clinical Research
Miami , Florida
ACTIVE_NOT_RECRUITING
Deluxe Health Center
Miami Lakes , Florida
ACTIVE_NOT_RECRUITING
Southern Indiana Clinical Trials
New Albany , Indiana
ACTIVE_NOT_RECRUITING
Equity Medical
New York , New York
ACTIVE_NOT_RECRUITING
Icahn School of Medicine at Mount Sinai
New York , New York
ACTIVE_NOT_RECRUITING
Renstar Medical Research
Ocala , Florida
COMPLETED
Allergy & Asthma Specialists, P.S.C.
Owensboro , Kentucky
COMPLETED
Alliance Dermatology and Mohs Center
Phoenix , Arizona
ACTIVE_NOT_RECRUITING
Leading Edge Dermatology
Plantation , Florida
ACTIVE_NOT_RECRUITING
NorCal Clinical Research
Rocklin , California
ACTIVE_NOT_RECRUITING
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio , Texas
ACTIVE_NOT_RECRUITING
Jordan Valley Dermatology & Research Center
South Jordan , Utah
ACTIVE_NOT_RECRUITING
Revival Research Institute, LLC
Troy , Michigan
ACTIVE_NOT_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
16.06.2025
Completion date
01.09.2026
Registry ID
NCT07006792
Source
clinicaltrials.gov
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