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Clinical Trials in the USA / NCT07006792
Active, not recruiting Phase 4

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

NCT07006792 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 4
Started
2025-06-16
Last updated
2026-05-22

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Lebrikizumab

Lebrikizumab: Administered SC

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (66)

FacilityCityRegionStatus
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology Birmingham Alabama
Research Solutions of Arizona Litchfield Park Arizona
Alliance Dermatology and Mohs Center Phoenix Arizona
California Dermatology & Clinical Research Institute Encinitas California
Dermatology Research Associates Los Angeles California
NorCal Clinical Research Rocklin California
Suncoast Research Associates Doral Florida
Encore Medical Research Hollywood Florida
Solutions Through Advanced Research Jacksonville Florida
Life Arc Research Centers - Miami Miami Florida
MCR Research Miami Florida
Health Clinical Research Miami Florida
Deluxe Health Center Miami Lakes Florida
Renstar Medical Research Ocala Florida
Leading Edge Dermatology Plantation Florida
Dermatology Affiliates Research Institute Atlanta Georgia
DeNova Research Chicago Illinois
Southern Indiana Clinical Research Center Columbus Indiana
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
Southern Indiana Clinical Trials New Albany Indiana
Equity Medical - Bowling Green Bowling Green Kentucky
Allergy & Asthma Specialists, P.S.C. Owensboro Kentucky
Foxhall Research Center Chevy Chase Maryland
Great Lakes Research Group, Inc. Bay City Michigan
Revival Research Institute, LLC Troy Michigan
Albuquerque Clinical Trials, Inc. Albuquerque New Mexico
Equity Medical New York New York
Icahn School of Medicine at Mount Sinai New York New York
Hickory Dermatology Research Center Hickory North Carolina
ObjectiveHealth - Goodlettsville Dermatology Research Goodlettsville Tennessee
Reveal Research Institute - Frisco Frisco Texas
Biopharma Informatic, LLC Houston Texas
Prime Clinical Research - Mansfield Mansfield Texas
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue San Antonio Texas
Jordan Valley Dermatology & Research Center South Jordan Utah
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

+ 26 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07006792 on ClinicalTrials.gov ↗ ← All trials in the USA