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A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3454738
LY3454738
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Pinnacle Research Group
  • Arkansas Research Trials, LLC
  • Northwest Arkansas Clinical Trials Center
  • First OC Dermatology
  • California Clinical Trials Medical Group
  • Revival Research Corporation
  • Global Health Research Center
  • ForCare Clinical Research
  • Palm Beach Research Center
  • Skin Sciences, PLLC
  • PAREXEL-Phase 1 Baltimore Harbor Hospital Center
  • Detroit Clinical Research Center
  • JUVA Skin & Laser Center
  • Wake Research Associates
  • Wright State Physicians Dermatology
  • Central Sooner Research
  • Center for Clinical Studies
  • Progressive Clinical Research
  • Premier Clinical Research
  • Dermatology
  • GCM Medical Group, PSC - Hato Rey Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LY3454738 - Part A

Placebo - Part A

LY3454738 - Part B

Placebo - Part B

LY3454738 - Part C

Placebo - Part C

Arm Description

Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants

Placebo administered IV to healthy participants

LY3454738 administered IV to healthy participants

Placebo administered IV to healthy participants

LY3454738 administered IV to participants with atopic dermatitis (AD)

Placebo administered IV to participants with AD

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Maximum Observed Drug Concentration (Cmax) of LY3454738
Cmax of LY3454738
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
AUC of LY3454738

Full Information

First Posted
November 20, 2018
Last Updated
October 5, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03750643
Brief Title
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Official Title
Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3454738 - Part A
Arm Type
Experimental
Arm Description
Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Arm Title
Placebo - Part A
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV to healthy participants
Arm Title
LY3454738 - Part B
Arm Type
Experimental
Arm Description
LY3454738 administered IV to healthy participants
Arm Title
Placebo - Part B
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV to healthy participants
Arm Title
LY3454738 - Part C
Arm Type
Experimental
Arm Description
LY3454738 administered IV to participants with atopic dermatitis (AD)
Arm Title
Placebo - Part C
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV to participants with AD
Intervention Type
Drug
Intervention Name(s)
LY3454738
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
LY3454738
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline up to Week 24
Title
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
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Maximum Observed Drug Concentration (Cmax) of LY3454738
Description
Cmax of LY3454738
Time Frame
Day 1 through Day 85 (Day 99 for Part C)
Title
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
Description
AUC of LY3454738
Time Frame
Day 1 through Day 85 (Day 99 for Part C)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Arkansas Research Trials, LLC
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Revival Research Corporation
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Global Health Research Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
JUVA Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022-3350
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wright State Physicians Dermatology
City
Dayton
State/Province
Ohio
ZIP/Postal Code
46435
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Dermatology
City
Los Prados
ZIP/Postal Code
00727
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1FiRtIYceUkw4QOKAMusai
Description
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema)

Learn more about this trial

A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis

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