A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis
2 other identifiers
interventional
128
2 countries
21
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 has three parts. Each participant will enroll in one part. The study will last 12 to 24 weeks, depending on part.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2018
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2021
CompletedOctober 6, 2021
October 1, 2021
2.8 years
November 20, 2018
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Maximum Observed Drug Concentration (Cmax) of LY3454738
Day 1 through Day 85 (Day 99 for Part C)
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
Day 1 through Day 85 (Day 99 for Part C)
Study Arms (6)
LY3454738 - Part A
EXPERIMENTALEscalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Placebo - Part A
PLACEBO COMPARATORPlacebo administered IV to healthy participants
LY3454738 - Part B
EXPERIMENTALLY3454738 administered IV to healthy participants
Placebo - Part B
PLACEBO COMPARATORPlacebo administered IV to healthy participants
LY3454738 - Part C
EXPERIMENTALLY3454738 administered IV to participants with atopic dermatitis (AD)
Placebo - Part C
PLACEBO COMPARATORPlacebo administered IV to participants with AD
Interventions
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Arkansas Research Trials, LLC
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 23, 2018
Study Start
November 29, 2018
Primary Completion
September 7, 2021
Study Completion
September 7, 2021
Last Updated
October 6, 2021
Record last verified: 2021-10-01
Data Sharing
- IPD Sharing
- Will not share