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LY3454738

Phase 2

Dermatitis, Atopic | Small molecule | Dermatology |Eli Lilly and Company|Trials Updated: Oct 6, 2021

LY3454738 development status

Highest phase Phase 2 (NCT04159701)
Phase scored for LLYPhase 1
Registered trials 4 across 1 sponsor since Nov 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

LY3454738 clinical trials

LY3454738 · 1 trial · 1 indication

Phase 1 1
NCT03750643A Study of LY3454738 in Healthy Participants and Participants With Atopic DermatitisDermatitis, Atopic
COMPLETED128 Analytics
PHASE1COMPLETED
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Dermatitis, AtopicUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3454738 - Part AEXPERIMENTALEscalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Placebo - Part APLACEBO_COMPARATORPlacebo administered IV to healthy participants
LY3454738 - Part BEXPERIMENTALLY3454738 administered IV to healthy participants
Placebo - Part BPLACEBO_COMPARATORPlacebo administered IV to healthy participants
LY3454738 - Part CEXPERIMENTALLY3454738 administered IV to participants with atopic dermatitis (AD)
Placebo - Part CPLACEBO_COMPARATORPlacebo administered IV to participants with AD

Interventions

NameTypeDescription
LY3454738DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites21

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 parti...

Countries:United StatesPuerto Rico
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Frequently asked questions about LY3454738

What is LY3454738 used for?

LY3454738 is an investigational small molecule being studied for atopic dermatitis, a form of eczema. It is being developed by Eli Lilly and Company as a potential treatment in dermatology. The compound has been evaluated in a Phase 1 clinical trial that included both healthy participants and participants with atopic dermatitis.

Who is developing LY3454738?

LY3454738 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the Phase 1 study of the compound in healthy volunteers and participants with atopic dermatitis.

What phase is LY3454738 in?

LY3454738 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials has LY3454738 been studied in?

LY3454738 has been studied in a single Phase 1 trial, NCT03750643, titled A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis. The trial was completed and enrolled 128 participants across the United States and Puerto Rico.

How was the Phase 1 trial of LY3454738 designed?

The Phase 1 trial NCT03750643 was a randomized, double-blind, placebo-controlled study. It enrolled 128 participants, including healthy volunteers and participants with atopic dermatitis, aged 18 years and older of all sexes. The study was conducted in the United States and Puerto Rico.