Dermatitis, Atopic
Conditions
Brief summary
The main purpose of this study is to investigate the safety, tolerability, and efficacy of the study drug known as LY3454738 in healthy participants and participants with atopic dermatitis. The study has three parts. Each participant will enroll in one part. The study will last 12 to 24 weeks, depending on part.
Interventions
DRUGLY3454738
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All: Must have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, for Parts A and B, and 18.0 to 45.0 kg/m², inclusive, for Part C and a minimum body weight of 50 kilograms * For PART A and B only, regarding the inclusion of healthy Japanese participants: Minimum age is 20 years and the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent and must have been born in Japan * AD: * Must have a diagnosis of AD for at least 12 months with either poor response to topical treatments or inability to use topical treatments * Must agree to use moisturizer daily throughout the treatment period
Exclusion criteria
* All: must not have previously completed a clinical trial with a molecule targeting interleukin-33 (IL-33) or its receptor * AD: * Must not have received certain topical medications for AD within 2 weeks prior to randomization * Must not have received certain oral medications for AD or received phototherapy within 4 weeks prior to randomization * Must not have received any antibody-based biologic agents (marketed or investigational) within 5 half lives (t1/2) of the drug prior to randomization * Must not have received intravenous, intramuscular, or intra-articular steroids in the past 6 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Week 24 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
| Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline | Week 12 | The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738 | Day 1 through Day 85 (Day 99 for Part C) | AUC of LY3454738 |
| Maximum Observed Drug Concentration (Cmax) of LY3454738 | Day 1 through Day 85 (Day 99 for Part C) | Cmax of LY3454738 |
Countries
Puerto Rico, United States
Outcome results
None listed