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

Lilly

Status and phase: Completed; Phase 1

Conditions: Dermatitis, Atopic

Treatments: Drug: LY3454738; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03750643

J1B-MC-FRCC (Other Identifier)

17090

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 6 patient groups, including a placebo group

LY3454738 - Part A

Experimental group

Description:

Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants

Treatment:

Drug: LY3454738

Drug: LY3454738

Placebo - Part A

Placebo Comparator group

Description:

Placebo administered IV to healthy participants

Treatment:

Drug: Placebo

LY3454738 - Part B

Experimental group

Description:

LY3454738 administered IV to healthy participants

Treatment:

Drug: LY3454738

Drug: LY3454738

Placebo - Part B

Placebo Comparator group

Description:

Placebo administered IV to healthy participants

Treatment:

Drug: Placebo

LY3454738 - Part C

Experimental group

Description:

LY3454738 administered IV to participants with atopic dermatitis (AD)

Treatment:

Drug: LY3454738

Drug: LY3454738

Placebo - Part C

Placebo Comparator group

Description:

Placebo administered IV to participants with AD

Treatment:

Drug: Placebo