Status:
COMPLETED
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05372419
Start Date
January 12 2023
End Date
February 17 2025
Last Update
June 11 2025
Active Locations (36)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
First OC Dermatology
Fountain Valley, California, United States, 92708
3
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
4
Axon Clinical Research
Inglewood, California, United States, 90301