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A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
200 patients around the world
Available in Brazil, Argentina, United States
Eli Lilly and Company
17Research sites
200Patients around the world
This study is for people with
Dermatitis
Atopic dermatitis
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Have chronic atopic dermatitis (AD) 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 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.
- Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening.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 infections requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment.Opportunistic infections.Chronic infections with duration of symptoms, signs, and/or treatment of 6 weeks or longer.Recurring infections, 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.Small molecules, including Janus kinase inhibitors.Phototherapy and photochemotherapy for AD.Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Psoriahue Medicina Interdisciplinaria - CABA, Buenos Aires
DOM Centro de Reumatología - CABA
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Instituto de Investigaciones Clínicas (IIC) - Rosario
CONEXA Investigación Clínica S.A.
Instituto Parra Dermatología
Instituto de Neumonología y Dermatología Dr. Luna
Fundación Respirar
INECO Neurociencias Oroño - Rosario
StudyADsolve
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Atopic dermatitis
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07006792
