A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Study Overview
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Brief Summary
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The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis

Official Title
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A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis, Eczema

Intervention / Treatment
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* Drug: Lebrikizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI. For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.) Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab. Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 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 + Placebo<br>Lebrikizumab will be given subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. | Drug: Lebrikizumab<br>* Administered SC<br>* Other names: LY3650150;Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) |  | Baseline through Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ |  | Baseline to Week 52 | 
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) from Baseline of Study KGBI by Visit in Study KGBJ |  | Baseline to Week 52 | 
| Percentage of Participants Achieving EASI-90 from Baseline of Study KGBI by Visit in Study KGBJ |  | Baseline to Week 52 | 
| Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ |  | Baseline to Week 52 | 
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score |  | Baseline, Week 52 | 
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD) |  | Baseline, Week 52 | 
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI |  | Baseline, Week 52 | 
| Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI |  | Baseline, Week 52 | 
| Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) |  | Baseline, Week 52 |