A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
NCT ID: NCT03750643
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2018-11-29
2021-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LY3454738 - Part A
Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
LY3454738
Administered IV
LY3454738
Administered SC
Placebo - Part A
Placebo administered IV to healthy participants
Placebo
Administered IV
LY3454738 - Part B
LY3454738 administered IV to healthy participants
LY3454738
Administered IV
Placebo - Part B
Placebo administered IV to healthy participants
Placebo
Administered IV
LY3454738 - Part C
LY3454738 administered IV to participants with atopic dermatitis (AD)
LY3454738
Administered IV
Placebo - Part C
Placebo administered IV to participants with AD
Placebo
Administered IV
Interventions
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LY3454738
Administered IV
LY3454738
Administered SC
Placebo
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Related Links
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A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema)
Other Identifiers
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J1B-MC-FRCC
Identifier Type: OTHER
Identifier Source: secondary_id
17090
Identifier Type: -
Identifier Source: org_study_id
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