TERMINATED

A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).

Official Title

A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

Quick Facts

Study Start:2023-06-21

Study Completion:2025-03-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05911841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Are candidates for systemic therapy. * Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit: * EASI score greater than or equal to (≥)16 * vIGA-AD score ≥3, and * ≥10% of BSA involvement (per EASI BSA). * Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.	* Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB. * Are currently being treated with topical or systemic therapy * Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.

Inclusion Criteria

Exclusion Criteria

* Are candidates for systemic therapy.
* Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:
* EASI score greater than or equal to (≥)16
* vIGA-AD score ≥3, and
* ≥10% of BSA involvement (per EASI BSA).
* Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.

* Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
* Are currently being treated with topical or systemic therapy
* Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.

Contacts and Locations

Principal Investigator

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)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Johnson Dermatology

Fort Smith, Arkansas, 72916

United States

Arkansas Research Trials

North Little Rock, Arkansas, 72217

United States

Dermatology Research Associates

Los Angeles, California, 90045

United States

Encore Medical Research

Hollywood, Florida, 33024

United States

Conquest Research

Winter Park, Florida, 32789

United States

Allergy and Asthma Specialist

Owensboro, Kentucky, 42301

United States

Revival Research Institute, LLC

Troy, Michigan, 48084

United States

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, 03801

United States

Metropolitan Dermatology - Clark

Kenilworth, New Jersey, 07033

United States

Oregon Dermatology and Research Center

Portland, Oregon, 97210

United States

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, 17011

United States

Progressive Clinical Research

San Antonio, Texas, 78213

United States

Center for Clinical Studies

Webster, Texas, 77598

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-21

Study Completion Date2025-03-14

Study Record Updates

Study Start Date2023-06-21

Study Completion Date2025-03-14

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis