Dermatitis, Atopic
Conditions
Brief summary
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
Interventions
DRUGLY3471851
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Nektar Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months * Have active AD according to study specific criteria * Be willing and able to undergo skin biopsies
Exclusion criteria
* Have received certain topical medications for AD within 14 days prior to baseline * Have received certain systemic medications for AD within 4 weeks prior to baseline * Have received LY3471851 previously
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 through Study Completion (up to Week 48) | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 | Postdose on Day 1 through Day 14 | PK: AUC of LY3471851 |
| PK: Trough Concentrations (Ctrough) of LY3471851 | Week 12 | PK: Ctrough of LY3471851 |
| PK: Maximum Concentration (Cmax) of LY3471851 | Postdose on Day 1 through Day 14 | PK: Cmax of LY3471851 |
Countries
United States
Outcome results
None listed