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

NCT ID: NCT06602219

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2025-09-04

Brief Summary

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The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY4100511 Dose 1

Participants will receive LY4100511 orally.

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally

LY4100511 Dose 2

Participants will receive LY4100511 orally.

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally

LY4100511 Dose 3

Participants will receive LY4100511 orally.

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally

Placebo

Placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY4100511

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

Site Status

Dermatology Trial Associates

Bryant, Arkansas, United States

Site Status

Zenith Research, Inc.

Beverly Hills, California, United States

Site Status

First OC Dermatology Research Inc

Fountain Valley, California, United States

Site Status

Center for Dermatology Clinical Research

Fremont, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Driven Research

Coral Gables, Florida, United States

Site Status

Direct Helpers Research Center

Hialeah, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

GCP Global Clinical Professionals, LLC

St. Petersburg, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Endeavor Clinical Trials Center - Dermatology - Skokie

Skokie, Illinois, United States

Site Status

Lawrence J Green, M.D, LLC

Rockville, Maryland, United States

Site Status

Center for Clinical Studies, LTD.LLP

Webster, Texas, United States

Site Status

Interior Dermatology Centre - Probity - PPDS

Kelowna, British Columbia, Canada

Site Status

Skin Care West

Nanaimo, British Columbia, Canada

Site Status

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, Canada

Site Status

Dermatrials Research Inc.

Hamilton, Ontario, Canada

Site Status

Lovegrove Dermatology - Probity - PPDS

London, Ontario, Canada

Site Status

DermEffects - Probity - PPDS

London, Ontario, Canada

Site Status

Lynderm Research Inc.

Markham, Ontario, Canada

Site Status

DermEdge Research

Mississauga, Ontario, Canada

Site Status

Clintrial s.r.o.

Prague, Praha 10, Czechia

Site Status

Pratia Pardubice a.s. - PRATIA - PPDS

Pardubice, , Czechia

Site Status

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status

Pratia Prague s.r.o. - PRATIA - PPDS

Prague, , Czechia

Site Status

Kozni ambulance Fialova, s.r.o. - CRC - PPDS

Prague, , Czechia

Site Status

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD

Augsburg, Bavaria, Germany

Site Status

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Carl Gustav Carus an der TU

Dresden, , Germany

Site Status

MensingDerma Research GmbH

Hamburg, , Germany

Site Status

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, Hungary

Site Status

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status

Gyongyosi Bugat Pal Korhaz

Gyöngyös, , Hungary

Site Status

MedMare Bt

Veszprém, , Hungary

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo, Hakkaido, Japan

Site Status

Katahira Dermatology Urology Clinic

Kagoshima, Kagoshima-ken, Japan

Site Status

Ohyama Dermatology Clinic

Kumamoto, Kumamoto, Japan

Site Status

Kume Clinic

Sakai-shi, Osaka, Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan

Site Status

Shirasaki dermatology clinic

Takaoka, Toyama, Japan

Site Status

Igarashi Dermatological Clinic

Tokyo, , Japan

Site Status

AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Clinical Best Solutions

Warsaw, Masovian Voivodeship, Poland

Site Status

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Pomeranian Voivodeship, Poland

Site Status

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Częstochowa, Silesian Voivodeship, Poland

Site Status

Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Angelius Provita

Katowice, , Poland

Site Status

Centrum Medyczne Reuma Park NZOZ

Warsaw, , Poland

Site Status

Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

Lodz, Łódź Voivodeship, Poland

Site Status

Countries

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United States Canada Czechia Germany Hungary Japan Poland

Other Identifiers

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J5C-MC-FOAB

Identifier Type: OTHER

Identifier Source: secondary_id

18845

Identifier Type: -

Identifier Source: org_study_id

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