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A Study of LY3471851 in Participants With Eczema

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3471851
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months
  • Have active AD according to study specific criteria
  • Be willing and able to undergo skin biopsies

Exclusion Criteria:

  • Have received certain topical medications for AD within 14 days prior to baseline
  • Have received certain systemic medications for AD within 4 weeks prior to baseline
  • Have received LY3471851 previously

Sites / Locations

  • Arkansas Research Trials, LLC
  • California Dermatology & Clinical Research Institute
  • Center For Dermatology Clinical Research, Inc.
  • Therapeutics Clinical Research
  • Clinical Science Institute
  • Miami Dermatology and Laser Research
  • ForCare Clinical Research
  • Medical Dermatology Specialists
  • Dawes Fretzin Clinical Research Group, LLC
  • Skin Sciences
  • Derm Center
  • ActivMed Practices and Research
  • Remington-Davis, Inc
  • Unity Clinical Research
  • Paddington Testing Company Inc
  • DermDox Centers for Dermatology
  • Studies in Dermatology, LLC
  • Rodgers Dermatology
  • Progressive Clinical Research
  • Complete Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LY3471851

Placebo

Arm Description

LY3471851 administered subcutaneously (SC)

Placebo administered SC

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

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
PK: AUC of LY3471851
PK: Trough Concentrations (Ctrough) of LY3471851
PK: Ctrough of LY3471851
PK: Maximum Concentration (Cmax) of LY3471851
PK: Cmax of LY3471851

Full Information

First Posted
September 5, 2019
Last Updated
January 24, 2023
Sponsor
Eli Lilly and Company
Collaborators
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04081350
Brief Title
A Study of LY3471851 in Participants With Eczema
Official Title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 15, 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)

3. Sponsor/Collaborators

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

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 learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.

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
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3471851
Arm Type
Active Comparator
Arm Description
LY3471851 administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
LY3471851
Other Intervention Name(s)
NKTR-358
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
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 through Study Completion (up to Week 48)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Description
PK: AUC of LY3471851
Time Frame
Postdose on Day 1 through Day 14
Title
PK: Trough Concentrations (Ctrough) of LY3471851
Description
PK: Ctrough of LY3471851
Time Frame
Week 12
Title
PK: Maximum Concentration (Cmax) of LY3471851
Description
PK: Cmax of LY3471851
Time Frame
Postdose on Day 1 through Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months Have active AD according to study specific criteria Be willing and able to undergo skin biopsies Exclusion Criteria: Have received certain topical medications for AD within 14 days prior to baseline Have received certain systemic medications for AD within 4 weeks prior to baseline Have received LY3471851 previously
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
Arkansas Research Trials, LLC
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Center For Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Miami Dermatology and Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Medical Dermatology Specialists
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Skin Sciences
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Derm Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
ActivMed Practices and Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Remington-Davis, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Paddington Testing Company Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
DermDox Centers for Dermatology
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Facility Name
Studies in Dermatology, LLC
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Rodgers Dermatology
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Complete Dermatology
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3Ex7XDC7Soi22zSKKaGtrA
Description
A Study of LY3471851 in Participants With Eczema

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