A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Completed · Phase 1 · Has a placebo group
Conditions studied: Dermatitis, Atopic
In brief
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.
Key facts
- Study ID
- NCT03750643
- Run by
- Eli Lilly and Company
- People needed
- 128
- Starts
- 2018-11-29
- Expected to finish
- 2021-09-07
- Last updated by the study team
- 2021-10-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pinnacle Research Group — Anniston, Alabama, United States
- Arkansas Research Trials, LLC — North Little Rock, Arkansas, United States
- Northwest Arkansas Clinical Trials Center — Rogers, Arkansas, United States
- First OC Dermatology — Fountain Valley, California, United States
- California Clinical Trials Medical Group — Glendale, California, United States
- Revival Research Corporation — Doral, Florida, United States
- Global Health Research Center — Miami Lakes, Florida, United States
- ForCare Clinical Research — Tampa, Florida, United States
- Palm Beach Research Center — West Palm Beach, Florida, United States
- Skin Sciences, PLLC — Louisville, Kentucky, United States
- PAREXEL-Phase 1 Baltimore Harbor Hospital Center — Baltimore, Maryland, United States
- Detroit Clinical Research Center — Farmington Hills, Michigan, United States
- JUVA Skin & Laser Center — New York, New York, United States
- Wake Research Associates — Raleigh, North Carolina, United States
- Wright State Physicians Dermatology — Dayton, Ohio, United States
- Central Sooner Research — Norman, Oklahoma, United States
- Center for Clinical Studies — Houston, Texas, United States
- Progressive Clinical Research — San Antonio, Texas, United States
- Premier Clinical Research — Spokane, Washington, United States
- Dermatology — Los Prados, Caguas, Puerto Rico
- GCM Medical Group, PSC - Hato Rey Site — San Juan, PR, Puerto Rico
Full record on ClinicalTrials.gov
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