A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lebrikizumab Participants will receive Lebrikizumab by subcutaneous (SC) injection. |
Drug: Lebrikizumab
Administered SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score [Baseline to Week 16]
Secondary Outcome Measures
- 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) [Baseline, Week 16]
Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
- 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.
- 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 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 Change from Baseline in SCORing Atopic Dermatitis (SCORAD) [Baseline, Week 16]
- Percentage Change from Baseline in SCORAD [Baseline, Week 24]
Eligibility Criteria
Criteria
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.
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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.
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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.
Exclusion Criteria:
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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
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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
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systemic (oral and/or parenteral) corticosteroid treatment, or
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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
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systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
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small molecules (e.g. JAK inhibitors)
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phototherapy and photochemotherapy for AD
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18499
- J2T-MC-KGBO