Clinical trial NCT03750643: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Week 24
measure: 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
timeFrame: Week 12
Secondary outcomes:
measure: Maximum Observed Drug Concentration (Cmax) of LY3454738
timeFrame: Day 1 through Day 85 (Day 99 for Part C)
measure: Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
timeFrame: Day 1 through Day 85 (Day 99 for Part C)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Doral
country: United States
facility: Revival Research Corporation
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Baltimore
country: United States
facility: PAREXEL-Phase 1 Baltimore Harbor Hospital Center
state: Maryland
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Dayton
country: United States
facility: Wright State Physicians Dermatology
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Los Prados
country: Puerto Rico
facility: Dermatology
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: