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| ID | Type | Description | Link |
|---|---|---|---|
| J1B-MC-FRCC | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3454738 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Week 24 |
| 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 | 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 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) of LY3454738 | Cmax of LY3454738 | Day 1 through Day 85 (Day 99 for Part C) |
| Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738 | AUC of LY3454738 |
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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:
Exclusion Criteria:
All: must not have previously completed a clinical trial with a molecule targeting interleukin-33 (IL-33) or its receptor
AD:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Arkansas Research Trials, LLC |
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| Label | URL |
|---|---|
| A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema) | View source |
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|
| LY3454738 | Drug | Administered SC |
|
| Placebo | Drug | Administered IV |
|
| Day 1 through Day 85 (Day 99 for Part C) |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States |
| Revival Research Corporation | Doral | Florida | 33122 | United States |
| Global Health Research Center | Miami Lakes | Florida | 33016 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | United States |
| PAREXEL-Phase 1 Baltimore Harbor Hospital Center | Baltimore | Maryland | 21225 | United States |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | United States |
| JUVA Skin & Laser Center | New York | New York | 10022-3350 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Wright State Physicians Dermatology | Dayton | Ohio | 46435 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Dermatology | Los Prados | Caguas | 00727 | Puerto Rico |
| GCM Medical Group, PSC - Hato Rey Site | San Juan | PR | 00917 | Puerto Rico |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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