A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/21/2019 |
| Start Date: | November 29, 2018 |
| End Date: | May 20, 2020 |
| Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Email: | ClinicalTrials.gov@Lilly.com |
| Phone: | 1-317-615-4559 |
Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis
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.
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.
Inclusion Criteria:
- All: Must have a body mass index of 18.0 to 32.0 kilograms per square meter and a
minimum body weight of 50 kilograms
- Japanese: 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 Criteria:
- All: Must not have received study drug in any clinical trial with an agent targeting
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, or dupilumab within 6
months, prior to randomization
- Must not have received intravenous, intramuscular, or intra-articular steroids in
the past 6 weeks prior to randomization
We found this trial at
2
sites
Baltimore, Maryland 21225
Principal Investigator: Azra Hussaini
Phone: 667-210-5300
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Glendale, California 91206
Principal Investigator: Hakop Gevorkyan
Phone: 818-254-1600
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