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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750643
• Other study ID #: 17090
• Secondary ID: J1B-MC-FRCC
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2018
• Est. completion date: September 7, 2021

Study information

• Verified date: October 1, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• LY3454738
Administered IV
• LY3454738
Administered SC
• Placebo
Administered IV

Locations

Country	Name	City	State
Puerto Rico	Dermatology	Los Prados
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
United States	Pinnacle Research Group	Anniston	Alabama
United States	PAREXEL-Phase 1 Baltimore Harbor Hospital Center	Baltimore	Maryland
United States	Wright State Physicians Dermatology	Dayton	Ohio
United States	Revival Research Corporation	Doral	Florida
United States	Detroit Clinical Research Center	Farmington Hills	Michigan
United States	First OC Dermatology	Fountain Valley	California
United States	California Clinical Trials Medical Group	Glendale	California
United States	Center for Clinical Studies	Houston	Texas
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Global Health Research Center	Miami Lakes	Florida
United States	JUVA Skin & Laser Center	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	Arkansas Research Trials, LLC	North Little Rock	Arkansas
United States	Wake Research Associates	Raleigh	North Carolina
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	Progressive Clinical Research	San Antonio	Texas
United States	Premier Clinical Research	Spokane	Washington
United States	ForCare Clinical Research	Tampa	Florida
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Maximum Observed Drug Concentration (Cmax) of LY3454738	Cmax of LY3454738	Day 1 through Day 85 (Day 99 for Part C)
Secondary	Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738	AUC of LY3454738	Day 1 through Day 85 (Day 99 for Part C)

External Links

•   A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema)