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

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: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: LY4100511

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 2

Contacts and Locations

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
      • Universitätsklinikum 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

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4100511 200 mg BID; Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.	Drug: LY4100511; Administered orally
Experimental: LY4100511 400 mg BID; Participants received LY4100511 400 mg administered orally BID for 12 weeks.	Drug: LY4100511; Administered orally
Experimental: LY4100511 800 mg QD; Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.	Drug: LY4100511; Administered orally
Placebo Comparator: Placebo BID; Participants received placebo administered orally BID for 12 weeks.	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)	Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)	Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Week 12
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12	Percentage of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement from baseline at Week 12. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe): 0 = Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may occur; 1 = Almost clear: Normal to pink lesions; no thickening; no or minimal focal scaling; 2 = Mild: Pink to light red color; slight thickening; mainly fine scaling; 3 = Moderate: Dull bright red erythema; moderate thickening; moderate scaling; 4 = Severe: Bright to deep red; severe thickening with hard edges; coarse scaling covering most or all lesions	Week 12
Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12	Percentage of participants achieving ≥50% reduction from baseline in PASI-50 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Week 12
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12	Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Week 12
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12	Percentage of participants achieving ≥90% reduction from baseline in PASI-90 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Week 12
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12	Percentage of participants achieving ≥100% reduction from baseline in PASI-100 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Week 12
Change From Baseline in PASI Score at Week 12	Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Baseline, Week 12
Percent Change From Baseline in PASI Score at Week 12	Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.	Baseline, Week 12
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12	Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value. BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.	Baseline, Week 12
Percent Change From Baseline in the Percentage of BSA Affected at Week 12	Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value. BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.	Baseline, Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)	Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.	Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511	Ctrough,ss of LY4100511	Predose at Day 8, 15, 29, 57 and 85
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511	The number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of LY4100511. A TEAE is defined as an AE that occurs during or after the first study drug administration and up to and including the follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (risk of death at the time of the event); Requires inpatient hospitalization or prolongation of existing hospitalization (excluding elective admission for a stable pre-existing condition); Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Other medically important event that may jeopardize the participant or require intervention to prevent the above outcomes	Baseline up to Week 12

Collaborators and Investigators

• 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

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 (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• 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