A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
- Registration Number
- NCT05372419
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent.
-
Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.
-
Participants who are Fitzpatrick phototype IV-VI
-
Participants who have chronic AD that has been present for ≥1 year before screening.
-
Have EASI ≥16 at baseline
-
Have IGA score ≥3 (Scale of 0 to 4) at baseline
-
Have ≥10% body surface area (BSA) of AD involvement at baseline
-
Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
-
Adolescents body weight must be ≥40 kg at baseline.
-
Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.
-
Contraceptive use - Male and/or female
- Male participants are not required to use any contraception except in compliance with specific local government study requirements.
- Female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. Women of non-child-bearing potential (non-WOCBP) may participate without any contraception requirements.
-
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
-
Have a current infection or chronic infection with hepatitis B virus (HBV) at screening, that is, positive for hepatitis B surface antigen (HBsAg) and/or polymerase chain reaction positive for HBV DNA
-
Have a current infection with hepatitis C virus (HCV) at screening, that is, positive for HCV RNA
-
Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).
-
Have uncontrolled asthma that
-
might require bursts of oral or systemic corticosteroids, or
-
required the following due to ≥1 exacerbations within 12 months before baseline
- systemic (oral and/or parenteral) corticosteroid treatment, or
- hospitalization for >24 hours.
-
-
Have known liver cirrhosis and/or chronic hepatitis of any etiology.
-
Had prior treatment with dupilumab
-
Had prior treatment with tralokinumab
-
Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.
-
Treatment with any of the following agents within 4 weeks prior to the baseline:
- systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants);
- small molecules (for example, Janus Kinase (JAK) inhibitors);
- phototherapy and photochemotherapy for AD.
-
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 non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lebrikizumab Lebrikizumab Participants will receive Lebrikizumab subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% reduction from baseline in EASI) Baseline to Week 16
- Secondary Outcome Measures
Name Time Method Percentage of Participants with an IGA score of 0 or 1 and a Reduction ≥2 Points from Baseline Baseline to Week 24 Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline Baseline to Week 16 Percentage of Participants with a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline Baseline to Week 24 Percentage of Participants with a Sleep-Loss Scale Score of ≥2 points at Baseline Who Achieve a 2-point Reduction from Baseline Baseline to Week 24 Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline Baseline to Week 24 Percentage of Participants with a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline Baseline to Week 24 Change from Baseline in Patient-Oriented Eczema Measure (POEM) Baseline, Week 16 Change from Baseline in POEM 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.
Percentage of Participants Achieving a ≥75% Reduction from Baseline in EASI-75 Baseline to 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 Change from Baseline in total EASI Baseline, Week 24 Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90 Baseline to Week 24 Percentage Change from Baseline in Pruritus NRS Score Baseline, Week 24 Percentage Change from Baseline in Sleep-Loss Scale Score Baseline, 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.
Change from Baseline in total EASI 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
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 of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI Baseline to 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 (35)
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Wallace Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Skin Care Physicians of Georgia
🇺🇸Macon, Georgia, United States
Sadick Research Group
🇺🇸New York, New York, United States
Arlington Research Center, Inc
🇺🇸Arlington, Texas, United States
Axon Clinical Research
🇺🇸Inglewood, California, United States
Center For Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Advanced Medical Research
🇺🇸Sandy Springs, Georgia, United States
Savin Medical Group, LLC
🇺🇸Miami Lakes, Florida, United States
Skin Care Research, Inc
🇺🇸Hollywood, Florida, United States
Allcutis Research, Inc.
🇺🇸Beverly, Massachusetts, United States
Wilmington Health Family Medicine
🇺🇸Wilmington, North Carolina, United States
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Avance Clinical Trials Inc
🇺🇸Laguna Niguel, California, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Encore Medical Research of Boynton Beach
🇺🇸Boynton Beach, Florida, United States
Solutions Through Advanced Research
🇺🇸Jacksonville, Florida, United States
Oakland Hills Dermatology
🇺🇸Auburn Hills, Michigan, United States
Revival Research Institute - Troy
🇺🇸Troy, Michigan, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Cura Clinical Research
🇺🇸Sherman Oaks, California, United States
Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Miami Dermatology and Laser Research
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
PureSkin Dermatology
🇺🇸Orlando, Florida, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Skin Specialists, P.C
🇺🇸Omaha, Nebraska, United States
Dermatology & Laser Center of Charleston
🇺🇸Charleston, South Carolina, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States