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Completed

NCT Number: NCT06602219

A Study of LY4100511 (DC-853) in 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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Interior Dermatology Centre - Probity - PPDS, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY4100511

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

  6. Percentage of Participants Achieving an sPGA Score of 0 or 1

    Time frame: Week 12

  7. Mean Change from Baseline in PASI Score

    Time frame: Week 12

  8. Percent Change from Baseline in PASI Score

    Time frame: Week 12

  9. Mean Change from Baseline in the Percentage of BSA Affected

    Time frame: Week 12

  10. Percent Change from Baseline in the Percentage of BSA affected

    Time frame: Week 12

  11. Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)

    Time frame: Predose up to 84 Days

  12. PK: Steady State Trough Concentration (Ctrough,ss)

    Time frame: Predose up to 84 Days

  13. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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