此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项维护研究，以调查Duvakitug在中度活跃的Crohn病的参与者中的功效和安全性 (STARSCAPE-2)

2026年10月20日 更新者：Sanofi

一项多中心，跨国，随机，双盲，安慰剂控制的第3阶段，维护研究，以评估杜瓦基蒂格（Duvakitug

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:

The study duration may be up to 286 weeks including:

  • 40-week Pivotal Maintenance Sub-Study
  • 240-week Open-Label Extension (OLE) Sub-Study
  • 45-day Follow-Up visit

Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

  • 40 weeks in the Pivotal Maintenance Sub-Study
  • 240 weeks in OLE Sub-Study

The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

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)

751

阶段

  • 第三阶段

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。

学习联系方式

  • 姓名：Trial Transparency email recommended (Toll free for US & Canada)
  • 电话号码：option 6 800-633-1610
  • 邮箱：Contact-US@sanofi.com

学习地点

  • 中国
      • Guangzhou、中国、510655
        • 招聘中
        • Investigational Site Number : 1560002
      • Huizhou、中国、516001
        • 招聘中
        • Investigational Site Number : 1560026
      • Shanghai、中国、200123
        • 招聘中
        • Investigational Site Number : 1560020
      • Wuxi、中国、214023
        • 招聘中
        • Investigational Site Number : 1560018
  • 乌克兰
      • Kyiv、乌克兰、2002
        • 招聘中
        • Investigational Site Number : 8040001
      • Kyiv、乌克兰、2091
        • 招聘中
        • Investigational Site Number : 8040013
      • Lviv、乌克兰、79000
        • 招聘中
        • Investigational Site Number : 8040004
      • Lviv、乌克兰、79019
        • 招聘中
        • Investigational Site Number : 8040005
      • Uzhhorod、乌克兰、88018
        • 招聘中
        • Investigational Site Number : 8040006
      • Vinnytsia、乌克兰、21013
        • 招聘中
        • Investigational Site Number : 8040010
      • Vinnytsia、乌克兰、21028
        • 招聘中
        • Investigational Site Number : 8040009
  • 乔治亚州
      • Tbilisi、乔治亚州、159
        • 招聘中
        • Investigational Site Number : 2680003
      • Tbilisi、乔治亚州、180
        • 招聘中
        • Investigational Site Number : 2680002
      • Tbilisi、乔治亚州、180
        • 招聘中
        • Investigational Site Number : 2680004
      • Tbilisi、乔治亚州、102
        • 招聘中
        • Investigational Site Number : 2680006
      • Tbilisi、乔治亚州、144
        • 招聘中
        • Investigational Site Number : 2680008
      • Tbilisi、乔治亚州、160
        • 招聘中
        • Investigational Site Number : 2680005
  • 以色列
      • Jerusalem、以色列、9103102
        • 招聘中
        • Investigational Site Number : 3760001
      • Tel Aviv、以色列、6423906
        • 招聘中
        • Investigational Site Number : 3760002
  • 保加利亚
      • Rousse、保加利亚、7000
        • 招聘中
        • Investigational Site Number : 1000007
      • Sofia、保加利亚、1618
        • 招聘中
        • Investigational Site Number : 1000001
    • Oblast Veliko Tirnovo
      • Gorna Oryahovitsa、Oblast Veliko Tirnovo、保加利亚、5100
        • 招聘中
        • Investigational Site Number : 1000003
  • 加拿大
      • Edmonton、加拿大、T6G 2X8
        • 招聘中
        • Investigational Site Number : 1240004
      • Hamilton、加拿大、L8N 1Y2
        • 招聘中
        • Investigational Site Number : 1240009
      • London、加拿大、N6K 1M6
        • 招聘中
        • Investigational Site Number : 1240013
      • New Westminster、加拿大、BC V3L 3W4
        • 招聘中
        • Investigational Site Number : 1240006
      • Toronto、加拿大、M6A 3B4
        • 招聘中
        • Investigational Site Number : 1240003
  • 南非
      • Cape Town、南非、7405
        • 招聘中
        • Investigational Site Number : 7100002
      • Durban、南非、3610
        • 招聘中
        • Investigational Site Number : 7100004
      • Kempton Park、南非、1619
        • 招聘中
        • Investigational Site Number : 7100001
  • 台湾
      • Changhua County、台湾、500209
        • 招聘中
        • Investigational Site Number : 1580005
  • 塞尔维亚
      • Belgrade、塞尔维亚、11 080
        • 招聘中
        • Investigational Site Number : 6880002
  • 奥地利
      • Vienna、奥地利、1090
        • 招聘中
        • Investigational Site Number : 0400001
  • 巴西
      • São José do Rio Preto、巴西、15090-000
        • 招聘中
        • Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
  • 德国
    • Baden-Wurttemberg
      • Ulm、Baden-Wurttemberg、德国、89081
        • 招聘中
        • Investigational Site Number : 2760005
    • Saxony
      • Leipzig、Saxony、德国、4103
        • 招聘中
        • Investigational Site Number : 2760015
    • Schleswig-Holstein
      • Kiel、Schleswig-Holstein、德国、24105
        • 招聘中
        • Investigational Site Number : 2760001
  • 意大利
      • Rozzano、意大利、20089
        • 招聘中
        • Investigational Site Number : 3800003
      • Turin、意大利、10128
        • 招聘中
        • Investigational Site Number : 3800005
  • 捷克语
      • Hradec Králové、捷克语、500 12
        • 招聘中
        • Investigational Site Number: 2030011
      • Prague、捷克语、150 00
        • 招聘中
        • Investigational Site Number : 2030013
  • 摩尔多瓦
      • Chisinau、摩尔多瓦、MD-2025
        • 招聘中
        • Investigational Site Number : 4980003
      • Chisinau、摩尔多瓦、MD-2025
        • 招聘中
        • Investigational Site Number : 4980002
      • Chisinau、摩尔多瓦、MD-2068
        • 招聘中
        • Investigational Site Number : 4980004
  • 斯洛伐克
      • Bratislava、斯洛伐克、811 09
        • 招聘中
        • Investigational Site Number : 7030001
  • 新西兰
      • Lower Hutt、新西兰、5010
        • 招聘中
        • Investigational Site Number : 5540003
  • 日本
      • Kamakura、日本、247-0056
        • 招聘中
        • Investigational Site Number : 3920030
      • Nishinomiya、日本、663-8501
        • 招聘中
        • Investigational Site Number : 3920013
      • Tsu、日本、514-8507
        • 招聘中
        • Investigational Site Number : 3920009
  • 智利
      • Viña del Mar、智利、2540488
        • 招聘中
        • Investigational Site Number : 1520001
  • 比利时
      • Yvoir、比利时、5530
        • 招聘中
        • Investigational Site Number : 0560003
  • 波兰
      • Bydgoszcz、波兰、85-229
        • 招聘中
        • Investigational Site Number : 6160026
      • Elblag、波兰、82-300
        • 招聘中
        • Investigational Site Number : 6160013
      • Katowice、波兰、40-748
        • 招聘中
        • Investigational Site Number : 6160014
      • Kłodzko、波兰、57-300
        • 招聘中
        • Investigational Site Number : 6160030
      • Lublin、波兰、20-049
        • 招聘中
        • Investigational Site Number : 6160034
      • Rzeszów、波兰、35-326
        • 招聘中
        • Investigational Site Number : 6160025
      • Staszów、波兰、28-200
        • 招聘中
        • Investigational Site Number : 6160007
      • Szczecin、波兰、71-685
        • 招聘中
        • Investigational Site Number : 6160020
      • Torun、波兰、87-100
        • 招聘中
        • Investigational Site Number : 6160023
      • Wadowice、波兰、34-100
        • 招聘中
        • Investigational Site Number : 6160012
      • Warsaw、波兰、04-501
        • 招聘中
        • Investigational Site Number : 6160008
      • Wroclaw、波兰、52-416
        • 招聘中
        • Investigational Site Number : 6160006
      • Wroclaw、波兰、54-239
        • 招聘中
        • Investigational Site Number : 6160017
  • 澳大利亚
      • Salzburg、澳大利亚、5020
        • 招聘中
        • Investigational Site Number : 0400002
      • Vienna、澳大利亚、1190
        • 招聘中
        • Investigational Site Number : 0400007
    • Queensland
      • South Brisbane、Queensland、澳大利亚、4101
        • 招聘中
        • Investigational Site Number : 0360001
  • 瑞士
      • Basel、瑞士、CH-4058
        • 招聘中
        • Investigational Site Number : 7560002
      • Bern、瑞士、3012
        • 招聘中
        • Investigational Site Number : 7560001
  • 立陶宛
      • Kaunas、立陶宛、LT-50161
        • 招聘中
        • Investigational Site Number : 4400001
  • 美国
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • 招聘中
        • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
    • Florida
      • Kissimmee、Florida、美国、34741
        • 招聘中
        • Clinical Research of Osceola-Site Number: 8400013
      • Miami、Florida、美国、33125
        • 招聘中
        • Columbus Clinical Services LLc-Site Number: 8400038
      • Miami、Florida、美国、33175
        • 招聘中
        • Bioresearch Partner-Kendale Lakes-Site Number: 8400053
      • Orlando、Florida、美国、32806
        • 招聘中
        • Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
      • Tampa、Florida、美国、33607
        • 招聘中
        • NMC Research LLC-Site Number: 8400033
    • Illinois
      • Gurnee、Illinois、美国、60031
        • 招聘中
        • Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
    • Indiana
      • New Albany、Indiana、美国、47150
        • 招聘中
        • Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • 招聘中
        • GI Alliance - Baton Rouge-Site Number: 8400129
      • Mandeville、Louisiana、美国、70471
        • 招聘中
        • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
      • Metairie、Louisiana、美国、70006
        • 招聘中
        • GI Alliance - Metairie-Site Number: 8400124
      • Monroe、Louisiana、美国、71291
        • 招聘中
        • Delta Research Partners-Site Number: 8400087
    • Missouri
      • Liberty、Missouri、美国、64068
        • 招聘中
        • BVL Clinical Research-Site Number: 8400005
      • St Louis、Missouri、美国、63141
        • 招聘中
        • Gateway Gastroenterology-Site Number: 8400097
    • New York
      • Maspeth、New York、美国、11378
        • 招聘中
        • MedTraits NY-Site Number: 8400045
      • New York、New York、美国、10075
        • 招聘中
        • New York Gastroenterology Associates-Site Number: 8400009
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Health-Site Number: 8400091
      • New York、New York、美国、10065
        • 招聘中
        • Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • 招聘中
        • UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
      • Fayetteville、North Carolina、美国、28304
        • 招聘中
        • Cross Creek Medical Clinic-Site Number: 8400057
    • Ohio
      • Columbus、Ohio、美国、43202
        • 招聘中
        • Ohio Gastroenterology Group Inc.-Site Number: 8400006
      • Columbus、Ohio、美国、43210
        • 招聘中
        • OSU Wexner Medical Center-Site Number: 8400077
      • Columbus、Ohio、美国、43210
        • 招聘中
        • Medical Associates Research Group-Site Number: 8400063
      • Westlake、Ohio、美国、44145
        • 招聘中
        • North Shore Gastroenterology Research-Site Number: 8400130
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104-6243
        • 招聘中
        • University of Pennsylvania School of Medicine-Site Number: 8400072
      • Pittsburgh、Pennsylvania、美国、15212
        • 招聘中
        • The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
    • Rhode Island
      • Providence、Rhode Island、美国、02904
        • 招聘中
        • University Gastroenterology - GI Alliance-Site Number: 8400103
    • Texas
      • Lubbock、Texas、美国、79410
        • 招聘中
        • GI Alliance - Lubbock-Site Number: 8400092
      • Mesquite、Texas、美国、75149
        • 招聘中
        • SMS Clinical Research-Site Number: 8400035
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Gastroenterology Research of San Antonio LLC-Site Number: 8400054
      • Southlake、Texas、美国、76092
        • 招聘中
        • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
      • Tyler、Texas、美国、75701
        • 招聘中
        • Tyler Research Institute LLC-Site Number: 8400095
    • Washington
      • Vancouver、Washington、美国、98664
        • 招聘中
        • The Vancouver Clinic Inc. P.S.-Site Number: 8400090
    • Wyoming
      • Wyoming、Wyoming、美国、49519
        • 招聘中
        • Gastroenterology Associates of Western Michigan-Site Number: 8400060
  • 荷兰
      • Tilburg、荷兰、5022 GC
        • 招聘中
        • Investigational Site Number : 5280003
  • 韩国
      • Busan、韩国、48108
        • 招聘中
        • Investigational Site Number : 4100008
      • Gwangju、韩国、61453
        • 招聘中
        • Investigational Site Number : 4100007
      • Seoul、韩国、6351
        • 招聘中
        • Investigational Site Number : 4100006
      • Seoul、韩国、6973
        • 招聘中
        • Investigational Site Number : 4100002

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

16年 至 80年 (孩子、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:

  • Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
  • Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
  • OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion Criteria:

  • Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
  • Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo

SC injection as per protocol
药品：Placebo

Pharmaceutical form:Injection solution-Route of administration:SC injection
实验性的：Duvakitug dose 1

Subcutaneous (SC) injection as per protocol
药品：Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

其他名称：
  • SAR447189
实验性的：Du vakitug dose 2

SC injection as per protocol
药品：Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

其他名称：
  • SAR447189
实验性的：Du vakitug dose 3

SC injection as per protocol
药品：Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

其他名称：
  • SAR447189

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
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40
大体时间：Week 40

Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Week 40
Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
大体时间：Week 40

The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading.
Week 40
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40
大体时间：Week 40

Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Week 40

次要结果测量

结果测量
措施说明
大体时间
关键维护子研究队列1：在第40周获得无溃疡内窥镜检查的参与者的比例（在基线溃疡的参与者子集）
大体时间：第40周
第40周
关键维护子研究队列1：CD相关住院的发生率40周
大体时间：第0周到第40周
第0周到第40周
关键维护子研究队列1：随着时间的推移测量的杜瓦基蒂格的血清浓度
大体时间：第0周到第40周
第0周到第40周
关键维护子研究队列1：针对Duvakitug的治疗伴随抗体抗体（ADA）的发病率
大体时间：第0周到第40周
第0周到第40周
关键维护子研究队列1：治疗伴随不良事件的发病率（TEAE），特殊兴趣的TEAE（TEAES），严重的不良事件（Tesaes）和TEAE，导致中断永久性研究干预措施
大体时间：上次剂量后的第0至45天
上次剂量后的第0至45天
开放标签扩展子研究：TEAES，TEAES，TESAE和TEAESEDEAD的发病率到永久研究干预措施
大体时间：关键维护的第40周，直到上次剂量后的45天
关键维护的第40周，直到上次剂量后的45天
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
大体时间：Week 40

The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. Clinical Response by CDAI: decrease in CDAI score of 100 points or more from Baseline.
Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
大体时间：Week 40

The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline.
Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
大体时间：Week 40

The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Clinical Remission by CDAI: CDAI score <150. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline.
Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40
大体时间：Week 40

Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline.
Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
大体时间：Week 40

Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
大体时间：Week 40

Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
大体时间：Week 40

Clinical Remission by CDAI: CDAI score <150 and without corticosteroid use for CD for at least 12 weeks prior to assessment. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
大体时间：Week 40

Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline and without corticosteroid use for CD for at least 12 weeks prior to assessment.
Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI)
大体时间：Week 40

Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2)
大体时间：Week 40

Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40
大体时间：Baseline, Week 40

The PROMIS Fatigue Short Form 7a uses a 5-point Likert scale for each of its 7 items, resulting in a raw score range of 7 to 35. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, based on US national norms. Higher T-scores indicate greater fatigue.
Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
大体时间：Baseline, Week 40

Inflammatory Bowel Disease Questionnaire (IBDQ) instrument consist of 32 items exploring 4 dimensions: "bowel symptoms" (10 items), "systemic symptoms" (5 items), "emotional function" (12 items) and "social function" (5 items). The total IBDQ total score ranges from 32 to 224 with higher score indicating better quality of life.
Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
大体时间：Week 40

Numeric Rating Scale (NRS) for bowel urgency measures the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents "no urgency" and 10 signifies the "worst possible urgency".
Week 40

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

Sanofi

合作者

Teva Branded Pharmaceutical Products R&D 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1月22日

初级完成 (估计的)

2029年8月13日

研究完成 (估计的)

2034年3月20日

研究注册日期

首次提交

2025年9月15日

首先提交符合 QC 标准的

2025年9月15日

首次发布 (实际的)

2025年9月22日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月20日

最后验证

2026年10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

  • EFC18327
  • 2025-521037-86 (注册表标识符：CTIS)
  • U1111-1314-5471 (注册表标识符：ICTRP)
  • 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

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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.

订阅