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

Phase 1

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: LY3454738; Drug: Placebo

• Registration Number: NCT03750643
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Study Start: 2018-11-29
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2021-10-01
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3454738 - Part C	LY3454738	LY3454738 administered IV to participants with atopic dermatitis (AD)
Placebo - Part C	Placebo	Placebo administered IV to participants with AD
LY3454738 - Part A	LY3454738	Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Placebo - Part A	Placebo	Placebo administered IV to healthy participants
LY3454738 - Part B	LY3454738	LY3454738 administered IV to healthy participants
Placebo - Part B	Placebo	Placebo administered IV to healthy participants

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	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
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	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

Name	Time	Method
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738	Day 1 through Day 85 (Day 99 for Part C)	AUC of LY3454738
Maximum Observed Drug Concentration (Cmax) of LY3454738	Day 1 through Day 85 (Day 99 for Part C)	Cmax of LY3454738

Trial Locations

Locations (21)

Global Health Research Center; 🇺🇸 Miami Lakes, Florida, United States

PAREXEL-Phase 1 Baltimore Harbor Hospital Center; 🇺🇸 Baltimore, Maryland, United States

Revival Research Corporation; 🇺🇸 Doral, Florida, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Northwest Arkansas Clinical Trials Center; 🇺🇸 Rogers, Arkansas, United States

Palm Beach Research Center; 🇺🇸 West Palm Beach, Florida, United States

Arkansas Research Trials, LLC; 🇺🇸 North Little Rock, Arkansas, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States

Skin Sciences, PLLC; 🇺🇸 Louisville, Kentucky, United States

JUVA Skin & Laser Center; 🇺🇸 New York, New York, United States

Detroit Clinical Research Center; 🇺🇸 Farmington Hills, Michigan, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

Central Sooner Research; 🇺🇸 Norman, Oklahoma, United States

Wright State Physicians Dermatology; 🇺🇸 Dayton, Ohio, 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

GCM Medical Group, PSC - Hato Rey Site; 🇵🇷 San Juan, Puerto Rico

Dermatology; 🇵🇷 Los Prados, Puerto Rico