Actively Recruiting
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
Led by Takeda · Updated on 2025-11-05
408
Participants Needed
41
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks. There will be up to 20 study visits over 58 weeks to complete assessments.
CONDITIONS
Official Title
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosis of Crohn's Disease established at least 3 months before screening
- Moderately to severely active Crohn's Disease defined by PRO2 score of 14 to 34 and SES-CD score 6 6 (or 6 4 for isolated ileitis)
- Crohn's Disease involvement of the ileum and/or colon at minimum
- Participants with extensive colitis or pancolitis >8 years or limited colitis >12 years must have had surveillance colonoscopy within 12 months before screening
- Participants with family history or increased risk of colorectal cancer or age >50 years must be up-to-date on colorectal cancer surveillance
- Inadequate response, loss of response, or intolerance to at least one of corticosteroids, immunomodulators, or TNF-alpha antagonists
You will not qualify if you...
- Evidence of abdominal abscess at screening
- Extensive colonic resection, subtotal or total colectomy
- History of more than 3 small bowel resections or diagnosis of short bowel syndrome
- Tube feeding, defined formula diets, or parenteral alimentation within 21 days before first dose
- Ileostomy, colostomy, fixed symptomatic intestinal stenosis, or small bowel stenosis with prestenotic dilation
- Use of nonbiologic therapies (except permitted medications) or investigational nonbiologic therapies within 30 days before randomization
- Use of traditional Chinese medications within 30 days before randomization
- Previous exposure to approved or investigational anti-integrins or vedolizumab
- Use of topical treatments (5-ASA, corticosteroids, traditional Chinese medications) within 2 weeks before first dose
- Need for surgical intervention for Crohn's Disease during the study
- History or evidence of adenomatous colonic polyps not removed
- History or evidence of colonic mucosal dysplasia
- Active infection or treatment for intestinal pathogens within 28 days before first dose
- Chronic hepatitis B or C infection
- Active or latent tuberculosis
- Any congenital or acquired immunodeficiency
- Receipt of live vaccinations within 30 days before screening
- Clinically significant active infection within 30 days before or during screening
- Surgical procedure requiring general anesthesia within 30 days before enrollment or planned major surgery during study
- History of malignancy except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ
- History of major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
2
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
Actively Recruiting
3
Peking University First Hospital - Changqiao Campus
Beijing, Beijing Municipality, China, 100034
Completed
4
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
5
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
6
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
Actively Recruiting
7
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Actively Recruiting
8
The First Affiliated Hospital, Sun Yat-sen University - Main
Guangzhou, Guangdong, China, 510080
Actively Recruiting
9
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
10
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
11
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510630
Completed
12
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
13
Huizhou Central People's Hospital
Huizhou, Guangdong, China, 516001
Actively Recruiting
14
Qingyuan People's Hospital
Qingyuan, Guangdong, China, 511518
Completed
15
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
Actively Recruiting
16
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
17
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, China, 50051
Completed
18
The 2nd Affliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China, 150081
Actively Recruiting
19
Nanyang First People's Hospital
Nanyang, Henan, China, 474500
Actively Recruiting
20
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
21
Renmin Hospital of Wuhan University - Main Campus
Wuhan, Hubei, China, 430060
Actively Recruiting
22
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
23
Changzhou No.2 People's Hospital - Yanling Campus
Changzhou, Jiangsu, China, 213200
Actively Recruiting
24
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
25
Changshu No.2 People's Hospital
Suzhou, Jiangsu, China, 215516
Actively Recruiting
26
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Completed
27
The Second Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, China, 330008
Actively Recruiting
28
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, China, 110004
Actively Recruiting
29
People's Hospital of Ningxia Hui Aotonomous Region
Yinchuan, Ningxia, China, 750002
Completed
30
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Completed
31
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200022
Completed
32
Shanghai East Hospital - Main
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
33
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
34
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
35
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650100
Actively Recruiting
36
The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
37
The First Affiliated Hospital of Ningbo University - Fangqiao Campus
Ningbo, Zhejiang, China, 315010
Actively Recruiting
38
People's Hospital of Quzhou
Quzhou, Zhejiang, China, 324307
Completed
39
Taizhou Hospital of Zhejiang Province - Main
Taizhou, Zhejiang, China, 317000
Actively Recruiting
40
The First People's Hospital of Wenling
Taizhou, Zhejiang, China, 317599
Actively Recruiting
41
The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
Wenzhou, Zhejiang, China, 325000
Completed
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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