A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
- Registration Number
- NCT05369403
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
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All participants must have prior treatment with dupilumab meeting one of the following conditions:
- Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
- Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
- Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
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Participants who have chronic AD that has been present for ≥1 year before screening.
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Have EASI ≥16 at baseline
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Have IGA score ≥3 (Scale of 0 to 4) at baseline
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Have ≥10% body surface area (BSA) of AD involvement at baseline
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Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
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Adolescents body weight must be ≥40 kg at baseline.
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History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
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Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
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Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
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Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
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Have uncontrolled asthma that
-
might require bursts of oral or systemic corticosteroids, or
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required the following due to ≥1 exacerbations within 12 months before baseline
- systemic (oral and/or parenteral) corticosteroid treatment, or
- hospitalization for >24 hours.
-
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Have known liver cirrhosis and/or chronic hepatitis of any etiology.
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Had Dupilumab treatment within 4 weeks prior to baseline
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Had prior treatment with tralokinumab.
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Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
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Treatment with any of the following agents within 4 weeks prior to the baseline
- systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
- small molecules (e.g. JAK inhibitors)
- phototherapy and photochemotherapy for AD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lebrikizumab Lebrikizumab Participants will receive Lebrikizumab by subcutaneous (SC) injection.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score Baseline to Week 16
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving EASI-75 Baseline to Week 24 Change from Baseline in EASI Baseline, Week 24 Percentage of Participants with an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points from Baseline Baseline to Week 16 Percentage of Participants with an IGA Score of 0 or 1 and a Reduction ≥2 Points from Baseline Baseline to Week 24 Percentage Change from Baseline in EASI Baseline, Week 24 Percentage of Participants Achieving EASI-90 from Baseline Baseline to Week 24 Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) Baseline, Week 16 Participants \<16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline Baseline to Week 16 Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline Who Achieve at least 4-point Reduction Baseline to Week 16 Percentage Change from Baseline in Pruritus NRS Score Baseline, Week 24 Change from Baseline in Dermatology Life Quality Index (DLQI) Baseline, Week 16 Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
Percentage Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Baseline, Week 16 Percentage Change from Baseline in SCORAD Baseline, Week 24 Change from Baseline in Skin Pain NRS Baseline, Week 24 Change from Baseline in cDLQI Baseline, Week 24 Participants \<16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.
Percentage of Participants with a Pruritus NRS of ≥4 points at Baseline Who Achieve at least 4-point Reduction Baseline to Week 24 Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction Baseline to Week 24 Percentage of Participants with a Sleep-Loss Scale of ≥2 points at Baseline Who Achieve at least 2-point Reduction Baseline to Week 24 Change from Baseline in Sleep-Loss Scale Baseline, Week 24 Change from Baseline in DLQI Baseline, Week 24 Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
Trial Locations
- Locations (37)
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Skin Care Physicians of Georgia
🇺🇸Macon, Georgia, United States
Miami Dermatology and Laser Research
🇺🇸Miami, Florida, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Cura Clinical Research
🇺🇸Sherman Oaks, California, United States
Revival Research Institute - Troy
🇺🇸Troy, Michigan, United States
Total Vein and Skin LLC
🇺🇸Boynton Beach, Florida, United States
Dermatologists of Greater Columbus
🇺🇸Bexley, Ohio, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
Dermatology and Skin Surgery Center, PC
🇺🇸Exton, Pennsylvania, United States
OptiSkin Medical
🇺🇸New York, New York, United States
Spokane Dermatology Clinic
🇺🇸Spokane, Washington, United States
Dermatology and Advanced Aesthetics
🇺🇸Lake Charles, Louisiana, United States
Allcutis Research, Inc
🇺🇸Portsmouth, New Hampshire, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Avance Clinical Trials Inc
🇺🇸Laguna Niguel, California, United States
Hollywood Dermatology
🇺🇸Hollywood, Florida, United States
Encore Medical Research of Boynton Beach
🇺🇸Boynton Beach, Florida, United States
Allcutis Research, Inc.
🇺🇸Beverly, Massachusetts, United States
River Region Dermatology and Laser
🇺🇸Montgomery, Alabama, United States
Axon Clinical Research
🇺🇸Inglewood, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Wallace Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Advanced Medical Research
🇺🇸Sandy Springs, Georgia, United States
Ziaderm Research, LLC.
🇺🇸North Miami Beach, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Dermatology and Skin Cancer Specialists, LLC
🇺🇸Rockville, Maryland, United States
The Derm Institute of West Michigan
🇺🇸Caledonia, Michigan, United States
Oakland Hills Dermatology
🇺🇸Auburn Hills, Michigan, United States
Windsor Dermatology, P.C.
🇺🇸East Windsor, New Jersey, United States
Sadick Research Group
🇺🇸New York, New York, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States