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

September 11, 2025 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Interior Dermatology Centre - Probity - PPDS
      • Nanaimo, British Columbia, Canada, V9T1W1
        • Skin Care West
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Simcoderm Medical & Surgical Dermatology Centre
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research Inc.
      • London, Ontario, Canada, N6H 5L5
        • DermEffects - Probity - PPDS
      • London, Ontario, Canada, N6A 5R9
        • Lovegrove Dermatology - Probity - PPDS
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research
  • Czechia
      • Pardubice, Czechia, 530 02
        • Pratia Pardubice a.s. - PRATIA - PPDS
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia, 13000
        • Pratia Prague s.r.o. - PRATIA - PPDS
      • Prague, Czechia, 160 00
        • Kozni ambulance Fialova, s.r.o. - CRC - PPDS
    • Praha 10
      • Prague, Praha 10, Czechia, 10100
        • CLINTRIAL s.r.o.
  • Germany
      • Dresden, Germany, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU
      • Hamburg, Germany, 22391
        • MensingDerma research GmbH
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitatsklinikum Tubingen
    • Bavaria
      • Augsburg, Bavaria, Germany, 86150
        • Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitatsklinikum Frankfurt
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitatsklinikum Munster
  • Hungary
      • Gyöngyös, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz
      • Veszprém, Hungary, 8200
        • Medmare Bt
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft
  • Japan
      • Tokyo, Japan
        • Igarashi Dermatological Clinic
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 450-0003
        • Nagoya City University Hospital
    • Hakkaido
      • Sapporo, Hakkaido, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-4101
        • Ohyama Dermatology Clinic
    • Osaka
      • Sakai-shi, Osaka, Japan, 593-8324
        • Kume Clinic
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tachikawa, Tokyo, Japan, 190-0023
        • Tachikawa Dermatology Clinic
    • Toyama
      • Takaoka, Toyama, Japan, 933-0871
        • Shirasaki Dermatology Clinic
  • Poland
      • Katowice, Poland, 40-611
        • Centrum Medyczne Angelius Provita
      • Warsaw, Poland, 02-665
        • Centrum Medyczne Reuma Park NZOZ
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
        • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-710
        • Clinical Best Solutions
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-382
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Pomeranian Voivodeship, Poland, 81-537
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Poland, 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-332
        • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-436
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology Skin Health Center
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates
    • California
      • Beverly Hills, California, United States, 90212
        • Zenith Research, Inc.
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology Research Inc
      • Fremont, California, United States, 94538-1614
        • Center for Dermatology Clinical Research
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Driven Research
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • St. Petersburg, Florida, United States, 33713-8012
        • GCP Global Clinical Professionals, LLC
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
    • Illinois
      • Skokie, Illinois, United States, 60077-1049
        • Endeavor Clinical Trials Center - Dermatology - Skokie
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J Green, M.D, LLC
    • Texas
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies, LTD.LLP

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally
Experimental: LY4100511 Dose 1
Participants will receive LY4100511 orally.
Drug: LY4100511
Administered orally
Experimental: LY4100511 Dose 2
Participants will receive LY4100511 orally.
Drug: LY4100511
Administered orally
Experimental: LY4100511 Dose 3
Participants will receive LY4100511 orally.
Drug: LY4100511
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an sPGA Score of 0 (clear) or 1 (almost clear) with ≥2 grade Improvement from Baseline
Time Frame: Week 12
Week 12
Percentage of Participants Achieving ≥50% Reduction in PASI score (PASI 50)
Time Frame: Week 12
Week 12
Percentage of Participants Achieving ≥75% Reduction in PASI score (PASI 75)
Time Frame: Week 12
Week 12
Percentage of Participants Achieving ≥90% Reduction in PASI score (PASI 90)
Time Frame: Week 12
Week 12
Percentage of Participants Achieving 100% Reduction in PASI score (PASI 100)
Time Frame: Week 12
Week 12
Percentage of Participants Achieving an sPGA Score of 0 or 1
Time Frame: Week 12
Week 12
Mean Change from Baseline in PASI Score
Time Frame: Week 12
Week 12
Percent Change from Baseline in PASI Score
Time Frame: Week 12
Week 12
Mean Change from Baseline in the Percentage of BSA Affected
Time Frame: Week 12
Week 12
Percent Change from Baseline in the Percentage of BSA affected
Time Frame: Week 12
Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
Time Frame: Predose up to 84 Days
Predose up to 84 Days
PK: Steady State Trough Concentration (Ctrough,ss)
Time Frame: Predose up to 84 Days
Predose up to 84 Days
Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the by the investigator to be related to study drug administration
Time Frame: Baseline to Week 12
A summary of AEs, SAEs and other non- serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events Module.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: 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), 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 Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Actual)

July 24, 2025

Study Completion (Actual)

September 4, 2025

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18845
  • J5C-MC-FOAB (Other Identifier: DCE853201)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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