A Study of LY3454738 in the Treatment of Adult Participants 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 describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).

Official Title
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A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: LY3454738
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are candidates for systemic therapy. ISA specific: Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit: EASI score greater than or equal to (≥)16 vIGA-AD score ≥3, and ≥10% of BSA involvement (per EASI BSA). Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study. Exclusion Criteria: ISA specific: Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB. Are currently being treated with topical or systemic therapy Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: LY3454738 Dose 1<br>Participants will receive LY3454738 subcutaneously (SC). | Drug: LY3454738<br>* Administered SC<br>|
| Experimental: LY3454738 Dose 2<br>Participants will receive LY3454738 SC. | Drug: LY3454738<br>* Administered SC<br>|
| Experimental: LY3454738 Dose 3<br>Participants will receive LY3454738 SC. | Drug: LY3454738<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo. | 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 Achieving Eczema Area and Severity Index (EASI) 75 |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving EASI-50 |  | Week 16 | 
| Percentage of Participants Achieving EASI-90 |  | Week 16 | 
| Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 |  | Week 16 | 
| Percentage of Participants Achieving SCORAD-90 |  | Week 16 | 
| Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1 |  | Week 16 | 
| Percentage of Participants Achieving ≥4-point improvement from baseline in Itch Numeric Rating Scale (NRS) in the Subset of Participants with ≥4-point Itch NRS at Baseline |  | Week 16 | 
| Mean Percent Change from Baseline in EASI |  | Baseline, Week 16 | 
| Mean Percent Change from Baseline in SCORAD |  | Baseline, Week 16 | 
| Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738 |  | Baseline to Week 16 |