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一项研究ixekizumab在临床实践中活跃的银屑病和超重或肥胖的参与者中启动ixekizumab后提高tirzepatide的有效性的研究

2026年9月18日 更新者：Eli Lilly and Company

一项第4阶段，前瞻性，开放标签的单臂研究，以评估ixekizumab在具有主动牛皮癣关节炎的成年参与者中启动Tirzepatide的有效性，并在临床实践中超重或肥胖。

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

阶段

  • 第四阶段

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

  • 波多黎各
      • Guaynabo、波多黎各、00968
        • Reuviva Research Center
      • San Juan、波多黎各、00918
        • CMRC Headlands, LLC
  • 美国
    • Arizona
      • Avondale、Arizona、美国、85392
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
      • Chandler、Arizona、美国、85225
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
      • Flagstaff、Arizona、美国、86001
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
      • Gilbert、Arizona、美国、85297
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
      • Glendale、Arizona、美国、85306
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
      • Mesa、Arizona、美国、85210
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
      • Phoenix、Arizona、美国、85032
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
      • Sun City、Arizona、美国、85351
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
      • Tucson、Arizona、美国、85748
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
      • Tucson、Arizona、美国、85704
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
    • California
      • Apple Valley、California、美国、92307
        • Medvin Clinical Research - Apple Valley
      • Covina、California、美国、91722
        • Medvin Clinical Research - Covina
      • Huntington Beach、California、美国、92648
        • Newport Huntington Medical Group
      • La Mesa、California、美国、91942
        • Purushotham & Akther Kotha MD, Inc
      • Riverside、California、美国、92508
        • Medvin Clinical Research - Riverside
      • San Diego、California、美国、92128
        • Rheumatology Center of San Diego
      • Santa Monica、California、美国、90404
        • Providence Saint John's Medical Foundation
      • Temecula、California、美国、92592
        • Medvin Clinical Research - Temecula
      • Tujunga、California、美国、91042
        • Medvin Clinical Research - Tujunga
      • Whittier、California、美国、90602
        • Medvin Clinical Research - Whittier
    • Florida
      • Kissimmee、Florida、美国、34741
        • Vida Clinical Research
      • Margate、Florida、美国、33063
        • Life Clinical Trials
      • Miami Beach、Florida、美国、33140
        • CZ Rheumatology
      • Palm Beach Gardens、Florida、美国、33410
        • Vitalia Medical Research
      • Tampa、Florida、美国、33614
        • International Center for Research
    • Georgia
      • Marietta、Georgia、美国、30060
        • Atlanta Research Center for Rheumatology
      • Waycross、Georgia、美国、31501
        • Satilla Rheumatology & Internal Medicine
    • Illinois
      • Chicago、Illinois、美国、60640
        • Great Lakes Clinical Trials - Ravenswood
      • Schaumburg、Illinois、美国、60195
        • Greater Chicago Specialty Physicians
      • Skokie、Illinois、美国、60076
        • Arnold Arthritis & Rheumatology
      • Willowbrook、Illinois、美国、60527
        • Willow Rheumatology and Wellness PLLC
    • Indiana
      • New Albany、Indiana、美国、47150
        • Lake Cumberland Rheumatology
    • Louisiana
      • Lake Charles、Louisiana、美国、70605
        • Accurate Clinical Research, Inc
    • Maryland
      • Cumberland、Maryland、美国、21502
        • Klein & Associates, M.D., P.A.
      • Hagerstown、Maryland、美国、21740
        • Klein & Associates, M.D., P.A.
    • Michigan
      • Saint Clair Shores、Michigan、美国、48081
        • Clinical Research Institute of Michigan, LLC
    • Montana
      • Kalispell、Montana、美国、59901
        • Logan Health Rheumatology
    • New York
      • Rochester、New York、美国、14642
        • University of Rochester Medical Center
    • North Carolina
      • Salisbury、North Carolina、美国、28144
        • Onsite Clinical Solutions, LLC - Brenner Ave
    • Ohio
      • Middleburg Heights、Ohio、美国、44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Tulsa、Oklahoma、美国、74137
        • Essential Medical Research
    • Tennessee
      • Jackson、Tennessee、美国、38305
        • West Tennessee Research Institute
      • Murfreesboro、Tennessee、美国、37128
        • AARA Clinical Research - Murfreesboro Medical Clinic
    • Texas
      • Colleyville、Texas、美国、76034
        • Precision Comprehensive Clinical Research Solutions - Colleyville
      • Fort Worth、Texas、美国、76109
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
      • Houston、Texas、美国、77089
        • Research Physicians Network, LLC
      • Houston、Texas、美国、77089
        • Accurate Clinical Research, Inc
      • Irving、Texas、美国、75039
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
      • Katy、Texas、美国、77494
        • Biopharma Informatic, LLC
      • The Woodlands、Texas、美国、77382
        • Advanced Rheumatology of Houston - Woodlands
      • Tomball、Texas、美国、77375
        • DM Clinical Research - TRA
    • Washington
      • Seattle、Washington、美国、98104
        • Seattle Rheumatology Associates PLLC
      • Spokane Valley、Washington、美国、99216
        • Arthritis Northwest, PLLC

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.
  • Body Mass Index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to <30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).
  • Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide.
  • Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).

Exclusion Criteria:

  • Have currently received ixekizumab for more than 4 months or less than 2 months.
  • Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).
  • Are currently enrolled in any other clinical study.
  • Have a known hypersensitivity to any component of tirzepatide.
  • Have a personal or family history of medullary thyroid cancer.
  • Have multiple endocrine neoplasia type 2.
  • Have type 1 diabetes mellitus.
  • Have a history of chronic or acute pancreatitis at any time before screening.
  • Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
  • Have a history of ketoacidosis or hyperosmolar state/coma.
  • Have a history of severe hypoglycemia unawareness within the 6 months before screening.
  • Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Tirzepatide

Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
药品：Tirzepatide

Administered SC

其他名称：
  • LY3298176

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 Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
大体时间：12 Months

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
12 Months
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
大体时间：12 Months

Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
12 Months

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
大体时间：Month 6 and Month 12

Percentage of participants achieving TJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
大体时间：Month 6 and Month 12

Percentage of participants achieving SJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
大体时间：Month 6 and Month 12

Percentage of participants achieving BSA ≤3%.
Month 6 and Month 12
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
大体时间：Month 6 and Month 12

The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.
Month 6 and Month 12
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
大体时间：Month 6 and Month 12

The Patient's Assessment of Arthritis Pain is a single-item, patient-reported outcome instrument, used to access the current severity of participants' joint pain in relation to their PsA on a horizontal VAS of 0 to 100 mm. The Patient's Assessment of Arthritis Pain is anchored by 2 verbal descriptors, "no pain" and "as severe as can imagine."
Month 6 and Month 12
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
大体时间：Month 6 and Month 12

The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Month 6 and Month 12
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
大体时间：Month 6 and Month 12

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6 and Month 12
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
大体时间：Month 6 and Month 12

FACIT-F is a patient-reported, 13-item questionnaire that specifically assess the self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses 0 ("not at all") to 4 ("very much") Likert scale to assess fatigue and its impact in the past 7 days. Total score ranges from 0 to 52, based on a rating of 5-point Likert scale. Scores for negatively worded items are reversed, such that higher scores are better (that is, less fatigue).
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
大体时间：Month 6 and Month 12

The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
大体时间：Month 6 and Month 12

The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants Achieving a HAQ-DI score ≤0.5
大体时间：Month 6

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6
Percentage of Participants with ≥10% Weight Loss at Month 6
大体时间：Month 6

Percentage of participants with ≥10% weight loss at month 6.
Month 6
Mean Percent Change of Weight from Baseline
大体时间：Baseline, Month 6 and Baseline, Month 12

Mean percent change of weight from baseline.
Baseline, Month 6 and Baseline, Month 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

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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2025年3月6日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2025年3月3日

首先提交符合 QC 标准的

2025年3月4日

首次发布 (实际的)

2025年3月7日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9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

  • 27350
  • I1F-MC-RHDE (其他标识符：Eli Lilly and Company)

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

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 共享时间框架

Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD 共享访问标准

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

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

在美国制造并从美国出口的产品

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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