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)
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline — Week 16 The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline.
Trial sites (66)
Facility
City
Region
Status
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.
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.
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