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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Lebrikizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lebrikizumab<br>Participants will receive Lebrikizumab subcutaneously (SC). | Drug: Lebrikizumab<br>* Administered SC<br>* Other names: DRM06;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 total EASI |  | Baseline, Week 16 | 
| Percentage Change from Baseline in total EASI |  | Baseline, Week 24 | 
| Change from Baseline in total EASI |  | Baseline, Week 16 | 
| Change from Baseline in total EASI |  | Baseline, Week 24 | 
| Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90 |  | Baseline to Week 16 | 
| Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90 |  | 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 Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline |  | Baseline to Week 16 | 
| Percentage of Participants with a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline |  | Baseline to Week 24 | 
| Percentage Change from Baseline in Pruritus NRS Score |  | Baseline, Week 16 | 
| Percentage Change from Baseline in Pruritus NRS Score |  | Baseline, 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 16 | 
| 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 Change from Baseline in Sleep-Loss Scale Score |  | Baseline, Week 16 | 
| Percentage Change from Baseline in Sleep-Loss Scale Score |  | Baseline, 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 16 | 
| 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 | 
| Change from Baseline in Patient-Oriented Eczema Measure (POEM) |  | Baseline, Week 16 | 
| Change from Baseline in POEM |  | Baseline, Week 24 | 
| Change from Baseline in Dermatology Life Quality Index (DLQI) | Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study. | Baseline, Week 16 | 
| Change from Baseline in DLQI | Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study. | Baseline, Week 24 | 
| Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) | Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study. | Baseline, Week 16 | 
| Change from Baseline in cDLQI | Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study | Baseline, Week 24 | 
| Percentage of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI | Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study. | Baseline to Week 16 | 
| Percentage of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI | Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study. | Baseline to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema