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

NCT06602219 | Completed Phase 2 FDA Drug

• 2 other identifiers: 18845J5C-MC-FOAB
• Study Type: interventional
• Target: 222
• Locations: 7 countries
• Sites: 58

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75

  Week 12

Secondary Outcomes (13)

• Percentage of Participants Achieving an sPGA Score of 0 (clear) or 1 (almost clear) with ≥2 grade Improvement from Baseline

  Week 12

• Percentage of Participants Achieving ≥50% Reduction in PASI score (PASI 50)

  Week 12

• Percentage of Participants Achieving ≥75% Reduction in PASI score (PASI 75)

  Week 12

• Percentage of Participants Achieving ≥90% Reduction in PASI score (PASI 90)

  Week 12

• Percentage of Participants Achieving 100% Reduction in PASI score (PASI 100)

  Week 12

Study Arms (4)

LY4100511 Dose 1

EXPERIMENTAL

Participants will receive LY4100511 orally.

Drug: LY4100511

LY4100511 Dose 2

EXPERIMENTAL

Participants will receive LY4100511 orally.

Drug: LY4100511

LY4100511 Dose 3

EXPERIMENTAL

Participants will receive LY4100511 orally.

Drug: LY4100511

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY4100511 DRUG

Administered orally

LY4100511 Dose 1; LY4100511 Dose 2; LY4100511 Dose 3

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (58)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244, United States

Location

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

Zenith Research, Inc.

Beverly Hills, California, 90212, United States

Location

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538-1614, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Driven Research

Coral Gables, Florida, 33134, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

GCP Global Clinical Professionals, LLC

St. Petersburg, Florida, 33713-8012, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Endeavor Clinical Trials Center - Dermatology - Skokie

Skokie, Illinois, 60077-1049, United States

Location

Lawrence J Green, M.D, LLC

Rockville, Maryland, 20850, United States

Location

Center for Clinical Studies, LTD.LLP

Webster, Texas, 77598, United States

Location

Interior Dermatology Centre - Probity - PPDS

Kelowna, British Columbia, V1W 4V5, Canada

Location

Skin Care West

Nanaimo, British Columbia, V9T1W1, Canada

Location

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Dermatrials Research Inc.

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lovegrove Dermatology - Probity - PPDS

London, Ontario, N6A 5R9, Canada

Location

DermEffects - Probity - PPDS

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

Clintrial s.r.o.

Prague, Praha 10, 10100, Czechia

Location

Pratia Pardubice a.s. - PRATIA - PPDS

Pardubice, 530 02, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

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

Prague, 13000, Czechia

Location

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

Prague, 160 00, Czechia

Location

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

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

Augsburg, Bavaria, 86150, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Carl Gustav Carus an der TU

Dresden, 1307, Germany

Location

MensingDerma Research GmbH

Hamburg, 22391, Germany

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Gyongyosi Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

MedMare Bt

Veszprém, 8200, Hungary

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 450-0003, Japan

Location

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo, Hakkaido, 060-0063, Japan

Location

Katahira Dermatology Urology Clinic

Kagoshima, Kagoshima-ken, 890-0063, Japan

Location

Ohyama Dermatology Clinic

Kumamoto, Kumamoto, 861-4101, Japan

Location

Kume Clinic

Sakai-shi, Osaka, 593-8324, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Tachikawa Dermatology Clinic

Tachikawa, Tokyo, 190-0023, Japan

Location

Shirasaki dermatology clinic

Takaoka, Toyama, 933-0871, Japan

Location

Igarashi Dermatological Clinic

Tokyo, Japan

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Clinical Best Solutions

Warsaw, Masovian Voivodeship, 00-710, Poland

Location

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

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

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

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

Częstochowa, Silesian Voivodeship, 42-202, Poland

Location

Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

Szczecin, West Pomeranian Voivodeship, 70-332, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Centrum Medyczne Reuma Park NZOZ

Warsaw, 02-665, Poland

Location

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

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 25, 2024
• Primary Completion: July 24, 2025
• Study Completion: September 4, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

HU (4); CA (8); JP (9); US (15); PL (11); CZ (5); DE (6)