Actively Recruiting
Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis
Led by Takeda · Updated on 2025-12-23
402
Participants Needed
36
Research Sites
547 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ulcerative colitis established at least 3 months before screening by clinical and endoscopic evidence with histopathology report or sufficient supporting evidence
- Moderately to severely active ulcerative colitis with a complete Mayo score of 6-12 and endoscopic subscore 652 within 10 days prior to first dose
- Ulcerative colitis extending at least 15 cm from the rectum
- For extensive colitis or pancolitis >8 years, or left-sided colitis >12 years, documented surveillance colonoscopy within 12 months
- Up-to-date colorectal cancer surveillance for participants with risk factors such as family history or age over 50
- Inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, or TNF-alpha antagonists
You will not qualify if you...
- Presence of abdominal abscess or toxic megacolon at screening
- History of extensive colonic resection, subtotal or total colectomy
- Existing ileostomy, colostomy, or fixed symptomatic intestinal stenosis (reversed ileostomy or colostomy may be acceptable)
- Prior use of approved or investigational anti-integrin or MAdCAM-1 antagonist drugs, or rituximab
- Use of topical 5-ASA or corticosteroid enemas/suppositories or traditional Chinese medications within 2 weeks before first dose
- Current or planned surgical intervention for ulcerative colitis during the study
- History or evidence of unresected adenomatous colonic polyps or colonic mucosal dysplasia
- Diagnosis of Crohn's enterocolitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease with colitis, or microscopic colitis
- Recent (within 28 days) treatment for C. difficile infection or other intestinal pathogens
- Chronic hepatitis B or C infection
- Active or latent tuberculosis
- Congenital or acquired immunodeficiency including HIV infection or organ transplantation
- History of malignancy except certain treated skin or cervical cancers
- History of major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease
- Positive screening for progressive multifocal leukoencephalopathy (PML) symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Completed
2
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Completed
3
The First Affiliated Hospital of Nanchang University
Beijing, Beijing Municipality, China, 100730
Completed
4
Second Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, China, 400037
Completed
5
Army Specialty Medical Center of The Chinese People's Liberation Army
Chongqing, Chongqing Municipality, China, 400042
Completed
6
The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force
Fuzhou, Fujian, China, 350025
Completed
7
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
8
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China, 363000
Completed
9
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Completed
10
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Completed
11
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Completed
12
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
13
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
Actively Recruiting
14
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
15
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Completed
16
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
17
Renmin Hospital, Wuhan University
Wuhan, Hubei, China, 430060
Completed
18
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
19
The First Hospital of Jilin University
Changsha, Hunan, China, 410011
Actively Recruiting
20
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Completed
21
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Completed
22
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
23
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Completed
24
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
25
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Completed
26
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110022
Actively Recruiting
27
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Completed
28
The First Affiliated Hospital of Nanchang University
Shanghai, Shanghai Municipality, China, 100730
Completed
29
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
30
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Completed
31
The Sixth Affiliated Hospital of Sun Yat-sen University
Shanghai, Shanghai Municipality, China, 200072
Completed
32
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China, 030012
Actively Recruiting
33
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Completed
34
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Completed
35
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
36
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310016
Completed
Research Team
T
Takeda Study Registration Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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