COMPLETED

A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis

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 assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

Official Title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants With Moderate-to Severe Plaque Psoriasis

Quick Facts

Study Start:2024-10-25

Study Completion:2025-09-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06602219

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
* Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization * Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive). * Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention. * Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study	* Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator. * Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis. * Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus. * Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics). * Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/baseline.

Inclusion Criteria

Exclusion Criteria

* Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization
* Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive).
* Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention.
* Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study

* Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator.
* Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis.
* Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus.
* Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics).
* Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/baseline.

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)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244

United States

Dermatology Trial Associates

Bryant, Arkansas, 72022

United States

Zenith Research, Inc.

Beverly Hills, California, 90212

United States

First OC Dermatology Research Inc

Fountain Valley, California, 92708

United States

Center for Dermatology Clinical Research

Fremont, California, 94538-1614

United States

Dermatology Research Associates

Los Angeles, California, 90045

United States

Clinical Science Institute

Santa Monica, California, 90404

United States

Driven Research

Coral Gables, Florida, 33134

United States

Direct Helpers Research Center

Hialeah, Florida, 33012

United States

Renstar Medical Research

Ocala, Florida, 34470

United States

GCP Global Clinical Professionals, LLC

St. Petersburg, Florida, 33713-8012

United States

ForCare Clinical Research

Tampa, Florida, 33613

United States

Endeavor Clinical Trials Center - Dermatology - Skokie

Skokie, Illinois, 60077-1049

United States

Lawrence J Green, M.D, LLC

Rockville, Maryland, 20850

United States

Center for Clinical Studies, LTD.LLP

Webster, Texas, 77598

United States

Collaborators and Investigators

Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of 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 Date2024-10-25

Study Completion Date2025-09-04

Study Record Updates

Study Start Date2024-10-25

Study Completion Date2025-09-04

Terms related to this study

Additional Relevant MeSH Terms

Plaque Psoriasis