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维多珠单抗在患有中度至重度溃疡性结肠炎 (UC) 的儿童和青少年中的研究

2026年4月9日 更新者：Takeda

一项随机、双盲、3 期研究，以评估维多珠单抗静脉注射作为中度至重度活动性溃疡性结肠炎儿科受试者维持治疗的疗效和安全性，这些受试者在开放标签维多珠单抗静脉注射治疗后达到临床反应

Vedolizumab 是一种有助于减轻消化系统炎症和疼痛的药物。 在这项研究中，患有中度至重度溃疡性结肠炎的儿童和青少年将接受维多珠单抗治疗。

该研究的主要目的是检查参与者在接受维多珠单抗治疗后是否达到缓解。 缓解意味着症状改善或消失，内窥镜检查显示没有或只有有限的疾病迹象。

参与者将在 6 周内接受 3 次维多珠单抗输注。 然后，那些有临床反应的人将每 8 周接受一次 3 剂维多珠单抗中的 1 剂。 他们每次都会接受相同的剂量。

研究概览

地位

完全的

条件

干预/治疗

详细说明

在这项研究中被测试的药物被称为维多珠单抗。 Vedolizumab 正在接受测试，用于治疗患有中度至重度活动性 UC 的儿科参与者。 参加者必须对 CD 的至少一种现行护理标准 (SOC) 诱导和维持治疗失败、失去反应或不能耐受，包括独家和/或部分肠内营养疗法、免疫调节剂（例如，硫唑嘌呤 [AZA]、6-巯基嘌呤 [6-MP]、甲氨蝶呤 [MTX]）和肿瘤坏死因子-α (TNF-α) 拮抗剂。

该研究将招募大约 120 名患者。

在诱导期，参与者将根据基线体重在第 1 天、第 2 周和第 6 周接受 3 剂维多珠单抗静脉输注：

  • ≥30 公斤的参与者，维多珠单抗 300 毫克
  • 参与者 >15 至
  • 参与者体重 10 至 15 公斤，维多珠单抗 150 毫克

在第 14 周，达到临床反应的参与者将以 1:1 的比例随机分配（偶然，如掷硬币）到 2 个双盲剂量组（高剂量和低剂量），按之前的暴露/未能进行分层TNF-α拮抗剂治疗或未接受过TNF-α拮抗剂治疗，并按体重分组。 在维持期间，参与者将每 8 周 (Q8W) 接受维多珠单抗 IV 输注，直至第 46 周，如下所示：

  • ≥30 公斤的参与者，维多珠单抗 300 毫克（高剂量）
  • ≥30 公斤的参与者，维多珠单抗 150 毫克（低剂量）
  • 参与者 >15 至
  • 参与者 >15 至
  • 参与者体重 10 至 15 公斤，维多珠单抗 150 毫克（高剂量）
  • 参与者体重 10 至 15 公斤，维多珠单抗 100 毫克（低剂量）

在研究期间，剂量将对参与者和研究医生不知情（除非有紧急医疗需要）。 所有参与者都将通过静脉输注接受维多珠单抗。 在维持期期间表现出临床反应维持不足的参与者中，将根据疾病恶化时的体重以盲法方式增加剂量。 此外，允许使用皮质类固醇进行一次性抢救治疗。

这项多中心试验将在全球范围内进行。 第 54 周后，参与者可能有资格参加扩展研究。 在扩展研究中未翻身的参与者将在最后一次服用维多珠单抗后 18 周进行安全访问，然后进行 2 年的长期随访（最多 104 周）。 在此期间，将在最后一次研究药物给药后的 2 年内每 6 个月进行一次电话安全调查。

研究类型

介入性

注册 (实际的)

121

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。

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100045
        • Beijing Children's Hospital, Capital Medical University - PIN
    • Henan
      • Zhengzhou、Henan、中国、450000
        • Henan Children's Hospital Zhengzhou Children's Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201102
        • Children's Hospital of Fudan University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • The Children's Hospital Zhejiang University School of Medicine
  • 以色列
      • Haifa、以色列、3436212
        • Carmel Medical Center
      • Haifa、以色列、31096
        • Rambam Medical Center - PPDS
      • Petah Tikva、以色列、49100
        • Schneider Childrens Medical Center of Israel Petah Tikvah PIN
      • Tel Aviv、以色列、64239
        • Tel Aviv Sourasky Medical Center
    • Jerusalem
      • Jerusalem、Jerusalem、以色列、91031
        • Shaare Zedek Medical Center
      • Jerusalem、Jerusalem、以色列、91120
        • Hadassah Medical Center - PPDS
  • 克罗地亚
    • City of Zagreb
      • Zagreb、City of Zagreb、克罗地亚、10000
        • Klinika Za Djecje Bolesti Zagreb
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2S2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6H 3V4
        • British Columbia Children's Hospital
    • Ontario
      • London、Ontario、加拿大、N6A 5W9
        • London Health Sciences Centre
  • 匈牙利
      • Budapest、匈牙利、1085
        • Semmelweis Egyetem
      • Budapest、匈牙利、1033
        • Clinexpert Gyogycentrum
      • Miskolc、匈牙利、3526
        • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház
  • 希腊
      • Thessaloniki、希腊、546 42
        • Ippokratio General Hospital of Thessaloniki
    • Attica
      • Athens、Attica、希腊、115 27
        • Children's Hospital "Agia Sofia"
      • Chaïdári、Attica、希腊、124 62
        • Attikon University General Hospital
  • 意大利
      • Naples、意大利、280138
        • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2
    • Campania
      • Naples、Campania、意大利、80131
        • Azienda Ospedaliera Universitaria Federico II
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40133
        • Azienda USL di Bologna
    • Lazio
      • Rome、Lazio、意大利、00161
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
    • Monza E Brianza
      • Monza、Monza E Brianza、意大利、20900
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
    • Tuscany
      • Florence、Tuscany、意大利、50139
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
  • 日本
      • Kumamoto、日本、861-8520
        • Japanese Red Cross Kumamoto Hospital
      • Saitama、日本、330-8777
        • Saitama Children's Medical Center
    • Hukuoka
      • Kurume、Hukuoka、日本、830-0011
        • Kurume University Hospital
    • Tokyo
      • Bunkyo-Ku、Tokyo、日本、113-8431
        • Juntendo University Hospital
      • Setagaya-ku、Tokyo、日本、157-8535
        • National Center for Child Health and Development
  • 比利时
    • Antwerpen
      • Edegem、Antwerpen、比利时、2650
        • UZ Antwerpen
    • Brussels Capital
      • Jette、Brussels Capital、比利时、1090
        • Universitair Ziekenhuis Brussel - PIN
    • Vlaams Brabant
      • Leuven、Vlaams Brabant、比利时、3000
        • Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg
  • 波兰
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、30-663
        • Uniwersytecki Szpital Dziecięcy
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw、Masovian Voivodeship、波兰、04-736
        • Instytut 'Pomnik - Centrum Zdrowia Dziecka'
    • Podkarpackie Voivodeship
      • Rzeszów、Podkarpackie Voivodeship、波兰、35-302
        • Korczowski Bartosz, Gabinet Lekarski
    • Silesian Voivodeship
      • Katowice、Silesian Voivodeship、波兰、40-752
        • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
    • West Pomeranian Voivodeship
      • Szczecin、West Pomeranian Voivodeship、波兰、71-434
        • Twoja Przychodnia SCM
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、91-738
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
      • Lodz、Łódź Voivodeship、波兰、93-338
        • Instytut Centrum Zdrowia Matki Polki
  • 澳大利亚
    • New South Wales
      • Westmead、New South Wales、澳大利亚、2145
        • Children's Hospital at Westmead
    • Queensland
      • South Brisbane、Queensland、澳大利亚、4101
        • Queensland Childrens Hospital
    • Victoria
      • Clayton、Victoria、澳大利亚、3168
        • Monash Health, Monash Medical Centre
      • Parkville、Victoria、澳大利亚、3052
        • Royal Children's Hospital Melbourne - PIN
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85016-7710
        • Phoenix Childrens Hospital -1919 E Thompson Rd
    • California
      • San Diego、California、美国、92123
        • Rady Childrens Hospital San Diego - PIN
    • Georgia
      • Atlanta、Georgia、美国、30318-4833
        • Childrens Center For Digestive Healthcare
    • Illinois
      • Park Ridge、Illinois、美国、60068
        • Advocate Children's Hospital Park Ridge
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Boston Children's Hospital
    • Minnesota
      • Minneapolis、Minnesota、美国、55413
        • MNGI Digestive Health PA-Plymouth
      • Rochester、Minnesota、美国、55905-0001
        • Mayo Clinic - PIN
    • New Jersey
      • Morristown、New Jersey、美国、07960-6136
        • Goryeb Children's Hospital
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15224-1334
        • UPMC Children's Hospital of Pittsburgh-120 Lytton Ave
    • Texas
      • Houston、Texas、美国、77030-2358
        • Texas Childrens Hospital West Campus
    • Virginia
      • Roanoke、Virginia、美国、24013-2253
        • Carilion Children's Tanglewood Center
  • 英国
      • Cardiff、英国、CF14 4XW
        • Noahs Ark Childrens Hospital for Wales
    • London, City of
      • London、London, City of、英国、E1 1BB
        • The Royal London Hospital
      • London、London, City of、英国、WC1N 3JH
        • Great Ormond Street Hospital
    • West Midlands
      • Birmingham、West Midlands、英国、B4 6NH
        • Birmingham Women's and Children's NHS Foundation Trust
  • 韩国
    • Daegu Gwang'yeogsi
      • Daegu、Daegu Gwang'yeogsi、韩国、41404
        • Kyungpook National University Chilgok Hospital
    • Incheon Gwang'yeogsi
      • Seoul、Incheon Gwang'yeogsi、韩国、3080
        • Gachon University Gil Medical Center
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、韩国、06351
        • Samsung Medical Center
      • Seoul、Seoul Teugbyeolsi、韩国、21565
        • Seoul National University Hospital

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

2年 至 17年 (孩子)

接受健康志愿者

不

描述

纳入标准：

  1. 具有中度至重度活动性 UC，对其当前的护理标准 (SOC) 无反应或不耐受。
  2. 在筛选和参加研究时体重≥10 公斤。
  3. 在筛选前至少 1 个月诊断出中度至重度活动性 UC，定义为改良梅奥评分 5 至 9（梅奥内窥镜分项、大便频率分项和直肠出血分项的总和），梅奥内窥镜分项≥2（有存在粘膜脆性，不包括内窥镜子评分 1 并要求至少 2 分）。
  4. 对以下至少一种药物的治疗失败、失去反应或不耐受：皮质类固醇（例如，硫唑嘌呤 [AZA]、6-巯基嘌呤 [6-MP]、甲氨蝶呤 [MTX]）、免疫调节剂和/或肿瘤坏死因子 α (TNF-α) 拮抗剂治疗（例如英夫利昔单抗、阿达木单抗）。 这包括依赖皮质类固醇来控制症状的参与者，以及在尝试停用皮质类固醇时出现中度至重度疾病恶化的参与者。
  5. 至少有 UC 延伸至直肠近端的证据（即不限于直肠炎）。
  6. 患有持续时间 >8 年的广泛性结肠炎或全结肠炎或持续时间 >12 年的左侧结肠炎，必须在筛选前 12 个月内提供阴性监测结肠镜检查的书面证据。
  7. 根据全国公认的儿童疫苗接种时间表接种最新疫苗的参与者。

排除标准：

  1. 之前曾接触过已批准或正在研究的抗整合素，包括但不限于那他珠单抗、efalizumab、etrolizumab 或 Abrilumab (AMG 181)，或粘膜地址素细胞粘附分子-1 (MAdCAM-1) 拮抗剂或利妥昔单抗。
  2. 在筛选前 60 天或 5 个半衰期（以较长者为准）内接受过研究性生物制品；或在研究药物首次给药前 2 周内或筛选期间的任何时间批准的生物制剂或生物类似药。
  3. 患有活动性脑/脑膜疾病、进行性多灶性脑白质病 (PML) 或任何其他主要神经系统疾病（包括中风、多发性硬化症、脑肿瘤或神经退行性疾病）的体征/症状或病史。
  4. 在研究药物首次给药前 30 天内发生过具有临床意义的感染（例如，肺炎、肾盂肾炎、冠状病毒病 2019 [COVID-19]）。
  5. 在研究药物首次给药前 30 天内接受过任何活疫苗接种。
  6. 目前需要手术干预或预计在本研究期间需要手术干预 UC 的参与者。
  7. 进行过次全或全结肠切除术，或进行过空肠造口术、回肠造口术、结肠造口术、回肠肛袋或已知的固定性肠狭窄。
  8. 目前诊断为不确定的结肠炎的参与者。
  9. 具有提示单基因极早发性炎症性肠病临床特征的参与者。

  10. 患有活动性或潜伏性结核病 (TB) 的参与者，如在筛选后 30 天内或在筛选期间进行的诊断性结核病检测呈阳性所证明，定义为：

    • 阳性 QuantiFERON 测试或 2 次连续不确定的 QuantiFERON 测试，或
    • 结核皮试反应≥5 毫米。 注意：如果参与者已接种卡介苗疫苗，则应进行 QuantiFERON TB Gold 测试，而不是 TB 皮试。

  11. 患有慢性乙型肝炎病毒 (HBV) 感染*或慢性丙型肝炎病毒感染。

    • 但是，可以包括 HBV 免疫参与者（即乙型肝炎表面抗原阴性和乙型肝炎抗体阳性）。
  12. 除了成功治疗的非转移性皮肤鳞状细胞癌或基底细胞癌或宫颈局部原位癌外，参与者有不典型增生或恶性肿瘤病史的证据。
  13. 在筛选访视时对卵和/或寄生虫或粪便培养进行阳性粪便研究。
  14. 筛选访视时艰难梭菌粪便试验呈阳性。

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
实验性的：维持期：参与者≥30 kg，维多珠单抗 300 mg
Vedolizumab 300 mg，IV 输注，在维持期从第 14 周到第 46 周每 8 周 (Q8W) 一次。 第 14 周体重≥30 公斤且在第 14 周达到临床反应的参与者随机分配到该高剂量组，将接受维多珠单抗 300 毫克。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：维持期：参与者≥30 公斤，维多珠单抗 150 毫克
Vedolizumab 150 mg，IV 输注，Q8W，从第 14 周到第 46 周维持期。 第 14 周体重≥30 公斤且在第 14 周达到临床反应的参与者随机分配到该低剂量组，将接受 150 毫克维多珠单抗。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：维护期：参与者 >15 至
Vedolizumab 200 mg，IV 输注，Q8W，从第 14 周到第 46 周维持期。 第 14 周体重 >15 至
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：维护期：参与者 >15 至
Vedolizumab 100 mg，IV 输注，Q8W，从第 14 周到第 46 周维持期。 第 14 周体重 >15 至
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：维持期：参与者 10 至 15 公斤，维多珠单抗 150 毫克
Vedolizumab 150 mg，IV 输注，Q8W，从第 14 周到第 46 周维持期。 第 14 周体重为 10 至 15 公斤且在第 14 周达到临床反应的参与者随机分配到该高剂量组，将接受 150 毫克维多珠单抗。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：维持期：参与者 10 至 15 公斤，维多珠单抗 100 毫克
Vedolizumab 100 mg，IV 输注，Q8W，从第 14 周到第 46 周维持期。 第 14 周体重为 10 至 15 公斤且在第 14 周达到临床反应的参与者随机分配到该低剂量组，将接受 100 毫克维多珠单抗。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：诱导期：参与者≥30 公斤，维多珠单抗 300 毫克
Vedolizumab 300 mg，静脉内 (IV) 输注，在诱导期的第 1 天、第 2 周和第 6 周。 该组包括基线体重≥30 公斤的 UC 参与者。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：诱导期：参与者 >15 至 <30 公斤，维多珠单抗 200 毫克
Vedolizumab 200 mg，IV 输注，在诱导期的第 1 天、第 2 周和第 6 周。 该组包括基线体重 >15 至 <30 公斤的 UC 参与者。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯
实验性的：诱导期：参与者体重 10 至 15 公斤，维多珠单抗 150 毫克
维多珠单抗 150 mg，IV 输注，在诱导期的第 1 天、第 2 周和第 6 周。 该组包括基线体重为 10 至 15 公斤的 UC 参与者。
药品：维多珠单抗
维多珠单抗静脉输注。
其他名称：
  • MLN0002
  • ENTYVIO公司
  • 金特勒斯

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 With Clinical Remission at Week 54 Based on Modified Mayo Score
大体时间：At Week 54
Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy). Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 54

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Clinical Remission at Week 14 Based on Modified Mayo Score
大体时间：At Week 14
Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 14
Percentage of Participants With Sustained Clinical Remission at Week 54 Based on Modified Mayo Score
大体时间：At Week 54
Participants who had clinical remission at Week 14 were analyzed for sustained clinical remission at Week 54. Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 54
Percentage of Participants With Sustained Endoscopic Remission at Week 54
大体时间：At Week 54
Participants who had endoscopic remission at Week 14 were analyzed for sustained endoscopic remission at Week 54. Mayo endoscopic sub score (MES) was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.
At Week 54
Percentage of Participants With Endoscopic Response at Week 14
大体时间：At Week 14
Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.
At Week 14
Percentage of Participants With Endoscopic Response at Week 54
大体时间：At Week 54
Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.
At Week 54
Percentage of Participants With Corticosteroid-free Clinical Remission at Week 54
大体时间：At Week 54
Corticosteroid-free clinical remission based on the modified Mayo score was defined as when a participant meets the definition described in the primary endpoint and was off corticosteroids at least 12 weeks prior to and at Week 54 and without presence of any intercurrent event. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 54
Percentage of Participants With Clinical Remission at Week 54 Based on Complete Mayo Score
大体时间：At Week 54
Clinical remission based on complete Mayo score was a score (inclusive of physician global assessment [PGA]) of <=2 points with no individual sub score >1 and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease.
At Week 54
Serum Trough Concentrations of Vedolizumab Over Time
大体时间：Predose at Week 14 and post dose at Week 54
Serum trough concentration of vedolizumab was reported.
Predose at Week 14 and post dose at Week 54
Percentage of Participants With Positive Anti-vedolizumab Antibodies (AVA)
大体时间：Up to Week 54
AVA positive was defined as a confirmed AVA positive result.
Up to Week 54
Percentage of Participants With Positive Neutralizing AVA
大体时间：Up to Week 54
Positive Neutralizing AVA was defined as a positive result in the neutralizing AVA assay at any visit.
Up to Week 54
Percentage of Participants With Sustained Clinical Response at Week 54 Based on Complete Mayo Score
大体时间：At Week 54
Participants who had clinical response at Week 14 were analyzed for sustained clinical response at Week 54. Sustained refers to meeting the specific endpoint criteria at both Week 14 and Week 54. Sustained clinical response is defined as meeting the following criteria at both Week 14 and Week 54: reduction in complete Mayo score of >=3 points and >=30% from baseline with an accompanying decrease in rectal bleeding sub score of >=1 point or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease.
At Week 54
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score
大体时间：At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical response was where a participant achieved clinical response if they had a reduction of >=2 points and >=25% from the baseline partial Mayo score, including a >=1 point decrease in the Mayo stool frequency sub score and a >=1 point reduction in the rectal bleeding sub score or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score
大体时间：At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical remission based on partial Mayo score was defined as a partial Mayo score of <=2 points and no individual sub score >1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI)
大体时间：From first dose of study drug up to end of follow up (up to 3.7 years)
A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug through Week 54 for participants entering the extension study or the final safety visit 18 weeks after their last dose of study drug for those who do not enter the extension study or those who early terminate. A TESAE was defined as an undesirable event that was not present prior to medical treatment or an already present event that worsened either in intensity or frequency following the first dose of study drug, that occurred from the first dose of study drug to the day of last dose of study drug + 126 days. AESI was defined as an AE (serious or nonserious) of medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. AESIs include infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]).
From first dose of study drug up to end of follow up (up to 3.7 years)
Change From Baseline in Weight
大体时间：At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in weight was reported.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change From Baseline in Weight Z-score
大体时间：At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in weight Z-score was reported. Weight z-score expresses how an individual's measured weight compares to the expected weight of a reference population of the same age and sex, standardized using population growth charts. It represents the number of standard deviations (SDs) an individual's weight is above or below the mean of the reference population. Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change From Baseline in Height
大体时间：At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in height was reported.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change From Baseline in Linear Growth Z-score
大体时间：At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in linear growth Z-score were reported. Linear growth Z-score is a standardized measure that describes how far a measured height deviates from the median height of a reference population of the same age and sex based on established growth charts. It is expressed in units of standard deviations (SD). Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Number of Participants With Change From Baseline in Tanner Stage at Week 54
大体时间：At Week 54
Tanner stages are used to evaluate growth parameters. They are standardized for age, sex, and pubertal development, with Stage 1 representing the prepubertal stage and Stage 5 representing the fully mature adult stage. It measures Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). The data reported shows shifts in participants' Tanner stages from baseline to Week 54.
At Week 54

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

Takeda

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)

2021年10月19日

初级完成 (实际的)

2025年7月1日

研究完成 (实际的)

2025年7月1日

研究注册日期

首次提交

2021年3月1日

首先提交符合 QC 标准的

2021年3月1日

首次发布 (实际的)

2021年3月3日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月9日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MLN0002-3024
  • 2020-004300-34 (EudraCT编号)
  • jRCT2071210030 (注册表标识符：jRCT)
  • 2023-509018-12-00 (克蒂斯)

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

武田为符合条件的研究提供去识别化个体参与者数据 (IPD) 的访问权限，以帮助合格的研究人员实现合法的科学目标（武田的数据共享承诺可在 https://clinicaltrials.takeda.com/takedas-commitment?commitment= 5). 这些 IPD 将在数据共享请求获得批准后并根据数据共享协议的条款在安全的研究环境中提供。

IPD 共享访问标准

符合条件的研究的 IPD 将根据 https://vivli.org/ourmember/takeda/ 上描述的标准和流程与合格的研究人员共享。 对于获得批准的请求，研究人员将能够访问匿名数据（以根据适用的法律法规尊重患者的隐私）以及根据数据共享协议的条款实现研究目标所需的信息。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 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

是的

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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