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

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company222 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

222

Conditions

Plaque Psoriasis

Interventions

LY4100511DRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (58)

Outcomes

Primary Outcomes

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.

Time frame: Week 12

Secondary Outcomes

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)

Time frame: 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

Data from ClinicalTrials.gov

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Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

Zenith Research, Inc.

Beverly Hills, California, United States

First OC Dermatology Research Inc

Fountain Valley, California, United States

Center for Dermatology Clinical Research

Fremont, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Clinical Science Institute

Santa Monica, California, United States

Driven Research

Coral Gables, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

...and 48 more locations

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.

Time frame: Week 12

Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Week 12

Percent Change From Baseline in PASI Score at Week 12

Time frame: 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.

Time frame: Baseline, Week 12

Percent Change From Baseline in the Percentage of BSA Affected at Week 12

Time frame: Baseline, Week 12

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

Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.

Time frame: 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

Time frame: 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

Time frame: Baseline up to Week 12