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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03750643
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : November 23, 2018
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: LY3454738 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : January 28, 2022
Estimated Study Completion Date : January 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: LY3454738 - Part A
Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Drug: LY3454738
Administered IV

Drug: LY3454738
Administered SC

Placebo Comparator: Placebo - Part A
Placebo administered IV to healthy participants
Drug: Placebo
Administered IV

Experimental: LY3454738 - Part B
LY3454738 administered IV to healthy participants
Drug: LY3454738
Administered IV

Placebo Comparator: Placebo - Part B
Placebo administered IV to healthy participants
Drug: Placebo
Administered IV

Experimental: LY3454738 - Part C
LY3454738 administered IV to participants with atopic dermatitis (AD)
Drug: LY3454738
Administered IV

Placebo Comparator: Placebo - Part C
Placebo administered IV to participants with AD
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Week 24 ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  2. 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 [ Time Frame: Week 12 ]
    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 :
  1. Maximum Observed Drug Concentration (Cmax) of LY3454738 [ Time Frame: Day 1 through Day 85 ]
    Cmax of LY3454738

  2. Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738 [ Time Frame: Day 1 through Day 85 ]
    AUC of LY3454738



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 38.0 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: 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 prior to randomization
    • Must not have received intravenous, intramuscular, or intra-articular steroids in the past 6 weeks prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750643


Locations
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United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
United States, California
California Clinical Trials Medical Group
Glendale, California, United States, 91206
United States, Florida
Revival Research Corporation
Doral, Florida, United States, 33122
Global Health Research Center
Miami Lakes, Florida, United States, 33016
ForCare Clinical Research
Tampa, Florida, United States, 33613
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Kentucky
Skin Sciences, PLLC
Louisville, Kentucky, United States, 40217
United States, Maryland
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, United States, 21225
United States, Michigan
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
United States, Nevada
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
United States, Ohio
Wright State Physicians Dermatology
Dayton, Ohio, United States, 46435
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73071
United States, Texas
Progressive Clinical Research
San Antonio, Texas, United States, 78213
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03750643    
Other Study ID Numbers: 17090
J1B-MC-FRCC ( Other Identifier: Eli Lilly and Company )
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases