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Completed

NCT Number: NCT03750643

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

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dermatology, Los Prados, Caguas, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3454738

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

  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 outcomes

  1. Maximum Observed Drug Concentration (Cmax) of LY3454738

    Time frame: Day 1 through Day 85 (Day 99 for Part C)

    Cmax of LY3454738

  2. Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738

    Time frame: Day 1 through Day 85 (Day 99 for Part C)

    AUC of LY3454738

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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