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Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221036
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to assess the effect of vedolizumab intravenous IV as induction and maintenance treatment in Chinese participants with moderately to severely active ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Moderately to Severely Active Ulcerative Colitis Drug: Vedolizumab IV Drug: Placebo Phase 3

Detailed Description:

The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion. This study will investigate the efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants with moderately to severely active ulcerative colitis (UC).

The study will enroll approximately 302 moderately to severely active patients with ulcerative colitis.

The Induction Phase contained 2 cohorts of participants: Cohort 1 participants will be randomized 1:2 in a double-blinded manner to receive:

  • Vedolizumab IV 300 mg
  • Placebo IV

Cohort 2 participants will be treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis.

Participants will receive induction therapy of Vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6. At Week 10, participants will be assessed for clinical response based on complete clinic Mayo score. Results of Week 10 clinical response will determine the treatment pathway in maintenance phase.

In the Maintenance Phase, participants who received vedolizumab in the induction phase and achieved clinical response at Week 10 will be randomized 1:1 in a double-blinded manner to receive vedolizumab IV 300 mg or placebo starting from Week 14 (i.e., Weeks 14, 22, 30, 38, 46, and 54).

This multi-center trial will be conducted in China. The overall time to participate in this study is 60 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long term follow-up safety survey.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : August 14, 2023
Estimated Study Completion Date : October 9, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: Induction Phase: Vedolizumab 300 mg
Vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, and 6 during induction phase.
Drug: Vedolizumab IV
Vedolizumab IV infusion

Placebo Comparator: Induction Phase: Placebo
Matching placebo IV infusion at Weeks 0, 2, and 6 during induction phase.
Drug: Placebo
Matching-placebo IV infusion

Experimental: Maintenance Phase: Vedolizumab 300 mg
Participants who received vedolizumab IV 300 mg in induction phase and achieved clinical response at Week 10 will be randomized to receive vedolizumab 300 mg IV infusion at Weeks 14, 22, 30, 38, 46 and 54. Participants who did not achieve clinical response at Week 10 will receive vedolizumab 300 mg IV infusion every 4 weeks from Week 14 up to Week 58.
Drug: Vedolizumab IV
Vedolizumab IV infusion

Placebo Comparator: Maintenance Phase: Placebo
Participants who received vedolizumab IV 300 mg in induction phase and achieved clinical response at Week 10 will be randomized to receive placebo, IV infusion at Weeks 14, 22, 30, 38, 46 and 54. Participants who received matching placebo in the induction phase and achieved clinical response at Week 10 will continue to receive placebo at Week 14, 22, 30, 38, 46, and 54.
Drug: Placebo
Matching-placebo IV infusion




Primary Outcome Measures :
  1. Percentage of Participants with Clinical Response at Week 10 [ Time Frame: Week 10 ]
    Clinical response is defined as ≥3 points reduction in complete Mayo clinical score and ≥30% decrease from baseline score accompanied with ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding subscore ≤1. Mayo clinical score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.

  2. Percentage of Participants with Clinical Remission at Week 60 [ Time Frame: Week 60 ]
    Clinical remission is defined as complete Mayo clinic score ≤2 with no subscore >1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.


Secondary Outcome Measures :
  1. Percentage of Participants with Clinical Remission at Week 10 [ Time Frame: Week 10 ]
    Clinical remission is defined as complete Mayo clinic score ≤2 with no subscore >1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.

  2. Percentage of Participants with Mucosal Healing at Weeks 10 and 60 [ Time Frame: Weeks 10 and 60 ]
    Mucosal healing is defined as Mayo endoscopic subscore ≤1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.

  3. Percentage of Participants with Durable Clinical Response at Weeks 10 and 60 [ Time Frame: Weeks 10 and 60 ]
    Clinical response is defined as ≥3 points reduction in complete Mayo clinical score and ≥30% decrease from baseline score accompanied with ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding subscore ≤1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.

  4. Percentage of Participants with Durable Clinical Remission at Weeks 10 and 60 [ Time Frame: Weeks 10 and 60 ]
    Clinical remission is defined as complete Mayo clinic score ≤2 with no subscore >1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.

  5. Percentage of Participants Using Oral Corticosteroids at Baseline who have Discontinued Corticosteroids and are in Clinical Remission at Week 60 [ Time Frame: Week 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a diagnosis of ulcerative colitis (UC) established at least 3 months prior to Screening by clinical and endoscopic evidence corroborated by a histopathology report.
  2. Has moderately to severely active UC as determined by a complete Mayo score of 6-12 with an endoscopic subscore ≥2 within 10 days prior to the first dose of study drug. The endoscopy can be performed during the Screening Phase (Day -10 to Day -5 to allow for central reading prior to first dose at Week 0).
  3. Has evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
  4. Participants with extensive colitis or pancolitis of >8 years duration or left-sided colitis >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial Screening Visit (may be performed during screening).
  5. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance (may be performed during screening).
  6. Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: corticosteroids, immunomodulators, or tumor necrosis factor alpha (TNF-α) antagonists.

Exclusion Criteria:

  1. Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
  2. Has had extensive colonic resection, subtotal or total colectomy.
  3. Has an existing ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. A history of ileostomy or colostomy that has been reversed may be acceptable.
  4. Has had any previous exposure to approved or investigational anti-integrins (e.g., natalizumab, efalizumab, etrolizumab, or AMG-181) or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonist, or rituximab.
  5. Has used a topical (rectal) treatment with 5-acetyl salicylic acid (5-ASA) or corticosteroid enemas/suppositories or traditional Chinese medications for treatment of UC within 2 weeks of the administration of the first dose of study drug.
  6. Currently requires or is anticipated to require surgical intervention for UC during the study.
  7. Has a history or evidence of adenomatous colonic polyps that have not been removed, or has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.
  8. Has a suspected or confirmed diagnosis of Crohn's enterocolitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  9. Has evidence of or has had treatment for C. difficile infection or other intestinal pathogen within 28 days prior to randomization.
  10. Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
  11. Has active or latent TB.
  12. Has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  13. Has any history of malignancy, except for the following: (a) adequately treated non-metastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to randomization. Subjects with remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to randomization.
  14. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
  15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening or prior to the administration of the first dose of study drug at Week 0.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221036


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
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China, Anhui
Gastroenterology Recruiting
Hefei, Anhui, China, 230024
Contact: Site Contact    8613956038063    hnz1956@msn.com   
Principal Investigator: Naizhong Hu         
China, Beijing
Gastroenterology Recruiting
Beijing, Beijing, China, 100050
Contact: Site Contact    8613910702345    wuyongdong@medmail.com.cn   
Principal Investigator: Yongdong Wu         
Gastroenterology Recruiting
Beijing, Beijing, China, 100730
Contact: Site Contact    +8610110325    hongy72@163.com   
Principal Investigator: Hong Yang         
China, Chongqing
Gastroenterology Active, not recruiting
Chongqing, Chongqing, China, 400037
Gastroenterology Recruiting
Chongqing, Chongqing, China, 400042
Contact: Site Contact    8613883032812    chendf1981@163.com   
Principal Investigator: Dongfeng Chen         
China, Fujian
Gastroenterology Recruiting
Fuzhou, Fujian, China, 350025
Contact: Site Contact    8613860628134    wangwen1386@163.com   
Principal Investigator: Wen Wang         
Gastroenterology Recruiting
Xiamen, Fujian, China, 361004
Contact: Site Contact    8613806019655    wl720807@sina.com   
Principal Investigator: Lin Wang         
Gastroenterology Recruiting
Zhangzhou, Fujian, China, 363000
Contact: Site Contact    8613055964918    lyd0596@hotmail.com   
Principal Investigator: Yadong Lai         
China, Guangdong
Gastroenterology Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site Contact    8613802791808    wh-sha@163.com   
Principal Investigator: Weihong Sha         
Gastroenterology Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site Contact    8613802957089    chenminhu@vip.163.com   
Principal Investigator: Minhu Chen         
Gastroenterology Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Site Contact    86 10 80705506    liuside@163.com   
Principal Investigator: Side Liu         
Gastroenterology Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Site Contact    13502405878    helen_gao818@163.com; Helengao818@163.com   
Principal Investigator: Xiang Gao         
Gastroenterology Completed
Shantou, Guangdong, China, 515041
China, Hubei
Gastroenterology Recruiting
Wuhan, Hubei, China, 430000
Contact: Site Contact    8613035143646    houxh@medmail.com.cn   
Principal Investigator: Xiaohua Hou         
Gastroenterology Recruiting
Wuhan, Hubei, China, 430030
Contact: Site Contact    8613971107769    tiandeanwh@163.com   
Principal Investigator: Dean Tian         
Gastroenterology Recruiting
Wuhan, Hubei, China, 430060
Contact: Site Contact    8613098803507    812328105@qq.com   
Principal Investigator: Shiyun Tan         
China, Hunan
Gastroenterology Recruiting
Changsha, Hunan, China, 410008
Contact: Site Contact    8613787270539    meihuaxu2001@163.com   
Principal Investigator: Meihua Xu         
Gastroenterology Recruiting
Changsha, Hunan, China, 410011
Contact: Site Contact    8613974812392    liudeliang1964@163.com   
Principal Investigator: Deliang Liu         
Gastroenterology Recruiting
Changsha, Hunan, China, 410013
Contact: Site Contact    8613975198393    ssr-35403@163.com   
Principal Investigator: Xiaoyan Wang         
China, Jiangsu
Gastroenterology Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Site Contact    8613770771661    zouxiaoping795@hotmail.com   
Principal Investigator: Xiaoping Zou         
Gastroenterology Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Site Contact    8613951913128    guoxinz@njmu.edu.cn   
Principal Investigator: Guoxin Zhang         
Gastroenterology Recruiting
Wuxi, Jiangsu, China, 241023
Contact: Site Contact    8613358110715    xmzb1013@163.com   
Principal Investigator: Min Xia         
China, Jiangxi
Gastroenterology Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Site Contact    8613970090801    jyyfyzx@163.com   
Principal Investigator: Xuan Zhu         
China, Jilin
Gastroenterology Recruiting
Changchun, Jilin, China, 130000
Contact: Site Contact    8613756661648    chxuhong@163.com   
Principal Investigator: Hong Xu         
China, Liaoning
Gastroenterology Recruiting
Shenyang, Liaoning, China, 110022
Contact: Site Contact    8618940251666    zhengchangqing88@163.com   
Principal Investigator: Changqing Zheng         
China, Ningxia
Gastroenterology Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Site Contact    8613995218678    shaoqiynh@163.com   
Principal Investigator: Shaoqi Yang         
China, Shanghai
Gastroenterology Recruiting
Shanghai, Shanghai, China, 200025
Contact: Site Contact    8613817815616    jimmyzj64@medmail.com.cn   
Principal Investigator: Jie Zhong         
Gastroenterology Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site Contact    8613817783888    shen.xizhong@zs-hospital.sh.cn   
Principal Investigator: Xizhong Shen         
Gastroenterology Recruiting
Shanghai, Shanghai, China, 200072
Contact: Site Contact    8618917683431    liuzhanju88@126.com   
Principal Investigator: Zhanju Liu         
Gastroenterology Recruiting
Shanghai, Shanghai, China, 200092
Contact: Site Contact    8613818868519    13818868519@163.com   
Principal Investigator: Jiangao Fan         
China, Sichuan
Gastroenterology Recruiting
Chengdu, Sichuan, China, 610041
Contact: Site Contact    8618980601283    wangyufang04@126.com   
Principal Investigator: yufang Wang         
China, Yunnan
Gastroenterology Recruiting
Kunming, Yunnan, China, 650032
Contact: Site Contact    8613708498467    1269810285@qq.com   
Principal Investigator: Yinglei Miao         
China, Zhejiang
Gastroenterology Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site Contact    8613757118653    chenyan@cccf4u.com   
Principal Investigator: Yan Chen         
Gastroenterology Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Site Contact    8657186006642    caoq@srrsh.com   
Principal Investigator: Qian Cao         
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03221036    
Other Study ID Numbers: Vedolizumab-3033
U1111-1195-3994 ( Other Identifier: World Health Organisation )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vedolizumab
Gastrointestinal Agents