A Study 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 measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo 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
* Drug: Topical corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least: 12 months s if participants are ≥6 years of age, and 6 months if participants are 6 months to <6 years of age Have an EASI score ≥16 at the screening and baseline Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline Have ≥10% BSA of AD involvement at the screening and baseline. Exclusion Criteria: Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study. Treatment with the following prior to the baseline: An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer. Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to <20%. Treatment with a topical investigational drug within 2 weeks prior to the baseline. Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lebrikizumab (Cohort 1)<br>Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight. | Drug: Lebrikizumab<br>* Administered SC<br>* Other names: DRM06;Drug: Topical corticosteroid<br>* Topical corticosteroid<br>|
| Experimental: Lebrikizumab (Cohort 2)<br>Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight. | Drug: Lebrikizumab<br>* Administered SC<br>* Other names: DRM06;Drug: Topical corticosteroid<br>* Topical corticosteroid<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo matching lebrikizumab by SC injections with a TCS. | Drug: Placebo<br>* Placebo given SC<br>Drug: Topical corticosteroid<br>* Topical corticosteroid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline |  | Baseline to Week 16 | 
| Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score |  | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score |  | Baseline to Week 16 | 
| Percentage Change from Baseline in EASI Score |  | Baseline, Week 16 | 
| Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline |  | Baseline to Week 16 | 
| Percentage Change from Baseline in Pruritus NRS Score |  | Baseline, Week 16 | 
| Change from Baseline in Children Dermatology Life Quality Index (cDLQI) |  | Baseline, Week 16 | 
| Percentage of Participants with a Pruritus NRS Score of ≥4 points at Baseline Who Achieve Both EASI-75 and a ≥4-point Reduction in Pruritus NRS Score from Baseline |  | Baseline to Week 1 | 
| Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM) |  | Baseline, Week 16 | 
| Change from Baseline in Body Surface Area (BSA) |  | Baseline, Week 16 | 
| Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD) |  | Baseline, Week 16 | 
| Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score |  | Baseline to Week 16 | 
| Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration |  | Week 14 | 
| Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) |  | Week 14 |