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LY4100511 (Dice 853) 在中度至重度斑块状银屑病成人参与者中的 2 期剂量范围研究

2026年7月24日 更新者：DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

LY4100511 (DC-853) 治疗中重度斑块状银屑病成人参与者的 2 期、多中心、随机、双盲、安慰剂对照、平行组、剂量范围研究

本研究的主要目的是评估 LY4100511 在患有中重度斑块型银屑病的成年参与者中的安全性和有效性。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

222

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 基线第 1 天随机分组前 6 个月内有斑块状银屑病的临床诊断
  • 体重指数 (BMI) 必须为 18 至 40 公斤/平方米 (kg/m2)（含）。
  • 在第一剂研究干预之前，必须愿意停止银屑病的局部和/或全身治疗。
  • 必须同意在研究期间避免长时间暴露在阳光下并避免使用晒黑亭、太阳灯和其他紫外线源

排除标准：

  • 根据研究者的评估，在基线前 12 周内曾出现临床上显着的银屑病发作。
  • 有红皮病型银屑病、全身性或局限性脓疱型银屑病、主要是滴状银屑病、或药物引起或药物加剧的银屑病病史。
  • 患有除银屑病和银屑病关节炎以外的任何已知或疑似炎症性疾病诊断，包括但不限于类风湿性关节炎、结节病、IBD（克罗恩病或溃疡性结肠炎）或系统性红斑狼疮。
  • 被诊断为银屑病关节炎，需要或正在接受全身免疫抑制剂治疗（包括皮质类固醇、免疫抑制剂和生物制剂）。
  • 当前或近期患有急性活动性感染。 参与者必须没有确诊或疑似感染的症状或体征，并且必须在筛选前至少 30 天完成任何适当的抗感染治疗，直至随机/基线。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：LY4100511 200 mg BID
Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.
药品：LY4100511
口服给药
实验性的：LY4100511 400 mg BID
Participants received LY4100511 400 mg administered orally BID for 12 weeks.
药品：LY4100511
口服给药
实验性的：LY4100511 800 mg QD
Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.
药品：LY4100511
口服给药
安慰剂比较：Placebo BID
Participants received placebo administered orally BID for 12 weeks.
药品：安慰剂
口服给药

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
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)
大体时间：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 an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline, 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
大体时间：Baseline, 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
大体时间：Baseline, 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
大体时间：Baseline, 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)
大体时间：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
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
大体时间：Predose at Day 8, 15, 29, 57 and 85
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
大体时间：Baseline up to Week 12

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

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

调查人员

  • 研究主任：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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月25日

初级完成 (实际的)

2025年7月24日

研究完成 (实际的)

2025年9月4日

研究注册日期

首次提交

2024年9月16日

首先提交符合 QC 标准的

2024年9月16日

首次发布 (实际的)

2024年9月19日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 18845
  • J5C-MC-FOAB (其他标识符：DCE853201)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

研究提案获得批准并签署数据共享协议后，匿名的个体患者级别数据将在安全访问环境中提供。

IPD 共享时间框架

数据在美国和欧盟 (EU) 研究的适应症首次发表和批准后 6 个月提供，以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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