Status:
COMPLETED
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03750643
Start Date
November 29 2018
End Date
September 7 2021
Last Update
October 6 2021
Active Locations (21)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Arkansas Research Trials, LLC
North Little Rock, Arkansas, United States, 72117
3
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States, 72758
4
First OC Dermatology
Fountain Valley, California, United States, 92708