A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

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: 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. 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. 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 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 Dupilumab treatment within 4 weeks prior to baseline Had prior treatment with tralokinumab. Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline 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

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 by subcutaneous (SC) injection. | 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 in EASI Score |  | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving 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 EASI |  | Baseline, Week 16 | 
| Percentage Change from Baseline in EASI |  | Baseline, Week 24 | 
| Change from Baseline in EASI |  | Baseline, Week 16 | 
| Change from Baseline in EASI |  | Baseline, Week 24 | 
| Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline |  | Baseline to Week 16 | 
| Percentage of Participants Achieving EASI-90 from Baseline |  | Baseline to Week 24 | 
| 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 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 16 | 
| Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction |  | 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 of ≥2 points at Baseline Who Achieve at least 2-point Reduction |  | Baseline to Week 16 | 
| 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 16 | 
| Change from Baseline in Sleep-Loss Scale |  | Baseline, Week 24 | 
| Change from Baseline in Skin Pain NRS |  | Baseline, Week 16 | 
| Change from Baseline in Skin Pain NRS |  | 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 Change from Baseline in SCORing Atopic Dermatitis (SCORAD) |  | Baseline, Week 16 | 
| Percentage Change from Baseline in SCORAD |  | Baseline, Week 24 | 

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