Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03750643 | A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis | PHASE1 | COMPLETED | 128 | — | — | Nov 29, 2018 | Sep 7, 2021 | Oct 6, 2021 | 21 | United States, Puerto Rico |
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
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
| Arm | Type | Description |
|---|---|---|
| LY3454738 - Part A | EXPERIMENTAL | Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants |
| Placebo - Part A | PLACEBO_COMPARATOR | Placebo administered IV to healthy participants |
| LY3454738 - Part B | EXPERIMENTAL | LY3454738 administered IV to healthy participants |
| Placebo - Part B | PLACEBO_COMPARATOR | Placebo administered IV to healthy participants |
| LY3454738 - Part C | EXPERIMENTAL | LY3454738 administered IV to participants with atopic dermatitis (AD) |
| Placebo - Part C | PLACEBO_COMPARATOR | Placebo administered IV to participants with AD |
| Name | Type | Description |
|---|---|---|
| LY3454738 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
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 parti...