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一项评估MK-8690在中度至重度活动性溃疡性结肠炎受试者中的疗效和安全性的研究（MK-8690-002）

2026年11月9日 更新者：Merck Sharp & Dohme LLC

一项评估MK-8690在患有中度至重度活动性溃疡性结肠炎成人参与者中的疗效和安全性的2a期随机、双盲、安慰剂对照研究

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

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。

学习联系方式

学习地点

  • 加拿大
    • Alberta
      • Lethbridge、Alberta、加拿大、T1J 4G9
        • 招聘中
        • Prairie Institute of Liver and Luminal Advanced Research ( Site 1008)
        • 接触：
          • Study Coordinator
          • 电话号码：(587) 691 3756
    • Ontario
      • Toronto、Ontario、加拿大、M5T 2S8
        • 招聘中
        • Toronto Western Hospital ( Site 1006)
        • 接触：
          • Study Coordinator
          • 电话号码：416-603-5949
    • Quebec
      • Montreal、Quebec、加拿大、H2X 0C1
        • 招聘中
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001)
        • 接触：
          • Study Coordinator
          • 电话号码：514-890-8000
  • 哥伦比亚
    • Antioquia
      • Medellín、Antioquia、哥伦比亚、050001
        • 招聘中
        • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)
        • 接触：
          • Study Coordinator
          • 电话号码：+57 3134673355
    • Atlántico
      • Barranquilla、Atlántico、哥伦比亚、080020
        • 招聘中
        • Clinica de la Costa S.A.S. ( Site 1161)
        • 接触：
          • Study Coordinator
          • 电话号码：+573006528529
    • Cundinamarca
      • Bogota、Cundinamarca、哥伦比亚、110111
        • 招聘中
        • Fundacion Santa Fe de Bogota ( Site 1165)
        • 接触：
          • Study Coordinator
          • 电话号码：+57 3165243088
    • Valle del Cauca Department
      • Cali、Valle del Cauca Department、哥伦比亚、760032
        • 招聘中
        • Fundación Valle del Lili ( Site 1162)
        • 接触：
          • Study Coordinator
          • 电话号码：+573146824542
  • 希腊
    • Attica
      • Athens、Attica、希腊、10676
        • 招聘中
        • Evangelismos General Hospital of Athens ( Site 1362)
        • 接触：
          • Study Coordinator
          • 电话号码：+306977617000
      • Athens、Attica、希腊、115 27
        • 招聘中
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361)
        • 接触：
          • Study Coordinator
          • 电话号码：+302107763359
  • 德国
      • Brandenburg、德国、14770
        • 招聘中
        • Universitätsklinikum Brandenburg an der Havel ( Site 1323)
        • 接触：
          • Study Coordinator
          • 电话号码：+493381412679
    • Baden-Wurttemberg
      • Ulm、Baden-Wurttemberg、德国、89081
        • 招聘中
        • Universitaetsklinikum Ulm. ( Site 1324)
        • 接触：
          • Study Coordinator
          • 电话号码：+4973150044727
  • 意大利
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40138
        • 招聘中
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404)
        • 接触：
          • Study Coordinator
          • 电话号码：+39 0512144134
    • Milano
      • Rozzano、Milano、意大利、20089
        • 招聘中
        • Istituto Clinico Humanitas-IBD center ( Site 1401)
        • 接触：
          • Study Coordinator
          • 电话号码：+390282248282
  • 智利
    • Biobio
      • Concepción、Biobio、智利、4070022
        • 招聘中
        • Hospital Clinico Regional Dr. Guillermo Grant Benavente ( Site 1129)
        • 接触：
          • Study Coordinator
          • 电话号码：+56957585657
    • Region M. de Santiago
      • Santiago、Region M. de Santiago、智利、7650568
        • 招聘中
        • Clinica Alemana de Santiago ( Site 1124)
        • 接触：
          • Study Coordinator
          • 电话号码：+56992794676
      • Santiago、Region M. de Santiago、智利、7691236
        • 招聘中
        • Clínica MEDS La Dehesa ( Site 1123)
        • 接触：
          • Study Coordinator
          • 电话号码：+56992000269
  • 法国
    • Pas-de-Calais
      • Lens、Pas-de-Calais、法国、62300
        • 招聘中
        • Centre Hospitalier Dr Schaffner ( Site 1288)
        • 接触：
          • Study Coordinator
          • 电话号码：+33321691306
    • Pays de la Loire Region
      • Nantes、Pays de la Loire Region、法国、44300
        • 招聘中
        • Clinique Jules Verne ( Site 1284)
        • 接触：
          • Study Coordinator
          • 电话号码：+33251171652
  • 波兰
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、31-513
        • 招聘中
        • Promed P. Lach R. Glowacki s.j. Centrum Medyczne Promed ( Site 1447)
        • 接触：
          • Study Coordinator
          • 电话号码：+48124111398
    • Lower Silesian Voivodeship
      • Wroclaw、Lower Silesian Voivodeship、波兰、53-611
        • 招聘中
        • Melita Medical Sp Zoo ( Site 1442)
        • 接触：
          • Study Coordinator
          • 电话号码：+48717072111
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、00-189
        • 招聘中
        • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)
        • 接触：
          • Study Coordinator
          • 电话号码：+48783959687
      • Warsaw、Masovian Voivodeship、波兰、04-501
        • 招聘中
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)
        • 接触：
          • Study Coordinator
          • 电话号码：+48507091469
    • West Pomeranian Voivodeship
      • Szczecin、West Pomeranian Voivodeship、波兰、71-434
        • 招聘中
        • Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)
        • 接触：
          • Study Coordinator
          • 电话号码：+48914332919
  • 美国
    • California
      • Anaheim、California、美国、92805
        • 招聘中
        • Clinnova Research ( Site 1042)
        • 接触：
          • Study Coordinator
          • 电话号码：949-889-0249
      • Coronado、California、美国、92118
        • 招聘中
        • Southern California Research Center ( Site 1044)
        • 接触：
          • Study Coordinator
          • 电话号码：619-522-0330
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • 招聘中
        • Peak Gastroenterology Associates ( Site 1052)
        • 接触：
          • Study Coordinator
          • 电话号码：719-636-1201
      • Englewood、Colorado、美国、80113
        • 招聘中
        • South Denver Gastroenterology, PC ( Site 1068)
        • 接触：
          • Study Coordinator
          • 电话号码：303-406-4288
    • Florida
      • Inverness、Florida、美国、34452
        • 招聘中
        • Nature Coast Clinical Research ( Site 1045)
        • 接触：
          • Study Coordinator
          • 电话号码：352-341-2100
      • Miami、Florida、美国、33134
        • 招聘中
        • Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
        • 接触：
          • Study Coordinator
          • 电话号码：786-476-8790
      • Orlando、Florida、美国、32803
        • 招聘中
        • AdventHealth Orlando ( Site 1074)
        • 接触：
          • Study Coordinator
          • 电话号码：407-303-9921
    • Georgia
      • Macon、Georgia、美国、31201
        • 招聘中
        • Gastroenterology Associates of Central Georgia ( Site 1060)
        • 接触：
          • Study Coordinator
          • 电话号码：478-464-2600
    • Kansas
      • Kansas City、Kansas、美国、66160
        • 招聘中
        • University of Kansas Medical Center ( Site 1077)
        • 接触：
          • Study Coordinator
          • 电话号码：913-588-6019
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • 招聘中
        • Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)
        • 接触：
          • Study Coordinator
          • 电话号码：504-988-5110
    • Missouri
      • Liberty、Missouri、美国、64068
        • 招聘中
        • BVL Research - Kansas ( Site 1054)
        • 接触：
          • Study Coordinator
          • 电话号码：816-222-4241
  • 英国
    • Cambridgeshire
      • Cambridge、Cambridgeshire、英国、CB2 0QQ
        • 招聘中
        • Addenbrooke's Hospital ( Site 1525)
        • 接触：
          • Study Coordinator
          • 电话号码：+4401223596461
    • Lancashire
      • Bury、Lancashire、英国、BL9 7TD
        • 招聘中
        • Fairfield General Hospital ( Site 1524)
        • 接触：
          • Study Coordinator
          • 电话号码：+4401617783879
    • London, City of
      • London、London, City of、英国、SE1 9RT
        • 招聘中
        • Guys and St Thomas NHS Foundation Trust ( Site 1523)
        • 接触：
          • Study Coordinator
          • 电话号码：020 7188 8315
    • York
      • Huddersfield、York、英国、HD3 3EA
        • 招聘中
        • Huddersfield Royal Infirmary ( Site 1522)
        • 接触：
          • Study Coordinator
          • 电话号码：+4401484355434
  • 荷兰
    • Gelderland
      • Nijmegen、Gelderland、荷兰、6525 GA
        • 招聘中
        • Radboudumc ( Site 1650)
        • 接触：
          • Study Coordinator
          • 电话号码：0031 24-3619190
    • North Holland
      • Amsterdam、North Holland、荷兰、1081 HZ
        • 招聘中
        • Amsterdam UMC, locatie VUmc ( Site 1651)
        • 接触：
          • Study Coordinator
          • 电话号码：020-4446630
  • 韩国
      • Seoul、韩国、03181
        • 招聘中
        • Kangbuk Samsung Hospital ( Site 1601)
        • 接触：
          • Study Coordinator
          • 电话号码：+82-2-2001-8556
    • Kang-won-do
      • Wŏnju、Kang-won-do、韩国、26426
        • 招聘中
        • Wonju Severance Christian Hospital ( Site 1602)
        • 接触：
          • Study Coordinator
          • 电话号码：+82 33 741 0505
    • Kyonggi-do
      • Ansan-si、Kyonggi-do、韩国、15355
        • 招聘中
        • Korea University Ansan Hospital ( Site 1603)
        • 接触：
          • Study Coordinator
          • 电话号码：+82314127674

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 至 75年 (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

The main inclusion criteria include but are not limited to the following:

  • Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization
  • Has moderately to severely active UC
  • Has a weight ≥40 kg
  • Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments
  • Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable

The main exclusion criteria include but are not limited to the following:

  • Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
  • Has a current diagnosis of fulminant colitis and/or toxic megacolon
  • Has UC limited to the rectum
  • Has a current or impending need for colostomy or ileostomy
  • Has had a total proctocolectomy or partial colectomy
  • Has UC exacerbation requiring hospitalization within 2 weeks before Screening
  • Has any active infection as specified in the protocol
  • Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
  • Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization or has a history of colorectal cancer at any time
  • Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
  • Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
  • Has received protocol-specified prohibited medications

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Period 1: MK-8690

Participants will receive MK-8690 via subcutaneous injection for 12 weeks.
药品：MK-8690

Solution for subcutaneous injection

其他名称：
  • PRA052
安慰剂比较：Period 1: Placebo

Participants will receive placebo via subcutaneous injection for 12 weeks.
其他：Placebo

Solution for subcutaneous injection
实验性的：Period 2: MK-8690

Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks.
药品：MK-8690

Solution for subcutaneous injection

其他名称：
  • PRA052
实验性的：Period 3: MK-8690

Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks.
药品：MK-8690

Solution for subcutaneous injection

其他名称：
  • PRA052

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 Clinical Remission Per Modified Mayo Score (MMS) at Week 12
大体时间：Week 12

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1 with no friability, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With One or More Adverse Events (AEs)
大体时间：Up to approximately 12 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported.
Up to approximately 12 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE
大体时间：Up to approximately 12 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 12 months
Percentage of Participants Achieving Clinical Response Per MMS at Week 12
大体时间：Week 12

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more from baseline, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
大体时间：Week 12

Endoscopic improvement is defined as ES of 0 or 1 with no friability. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12
Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12
大体时间：Week 12

pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant) and RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of less than or equal to 1.
Week 12
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
大体时间：Week 12

HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1 with no friability. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
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

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

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)

2026年3月24日

初级完成 (估计的)

2027年10月28日

研究完成 (估计的)

2028年12月21日

研究注册日期

首次提交

2026年3月4日

首先提交符合 QC 标准的

2026年3月4日

首次发布 (实际的)

2026年3月11日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11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

  • 8690-002
  • MK-8690-002 (其他标识符：MSD)
  • U1111-1326-7763 (注册表标识符：UTN)
  • 2025-523479-49-00 (注册表标识符：EU CT)
  • 2025 (美国 NIH 拨款/合同)

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

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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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