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

IDENTIFIERS
Trial Protocol: Vedolizumab-3033
Clinicaltrials.gov: NCT03221036
PURPOSE

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).

Recruiting
CN

Trial at a glance

What medical condition is being studied?   Ulcerative Colitis
What is the trial testing?   Vedolizumab IV, Placebo
Are placebos part of the trial?   Yes
How many participants are being enrolled?   302
When is the trial being conducted?    - 

Key requirements

Sex   
All
Age   
18 - 80 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
Induction Phase: Vedolizumab 300 mg: Vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, and 6 during induction phase.
Induction Phase: Placebo: Matching placebo IV infusion at Weeks 0, 2, and 6 during induction phase.
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.
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.
Intervention:   Vedolizumab IV, Placebo
Primary Outcome Measure(s):   
Percentage of Participants with Clinical Response at Week 10 [Time Frame: Week 10]
Percentage of Participants with Clinical Remission at Week 60 [Time Frame: Week 60]
Secondary Outcome Measure(s):   
Percentage of Participants with Clinical Remission at Week 10 [Time Frame: Week 10]
Percentage of Participants with Mucosal Healing at Weeks 10 and 60 [Time Frame: Weeks 10 and 60]
Percentage of Participants with Durable Clinical Response at Weeks 10 and 60 [Time Frame: Weeks 10 and 60]
Percentage of Participants with Durable Clinical Remission at Weeks 10 and 60 [Time Frame: Weeks 10 and 60]
Percentage of Participants Using Oral Corticosteroids at Baseline who have Discontinued Corticosteroids and are in Clinical Remission at Week 60 [Time Frame: Week 60]
Entry 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.

Trial Locations

Any
Recruiting
Completed
Any
RESULTS
Gastroenterology

Shushan District, Hefei, Anhui, China

Recruiting
5,885 miles (9,471 km)  awayfrom
Canada
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Gastroenterology

Dongcheng, Beijing, China

Recruiting
5,389 miles (8,673 km)  awayfrom
Canada
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Gastroenterology

Dongcheng, Beijing, China

Recruiting
5,389 miles (8,673 km)  awayfrom
Canada
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Gastroenterology

Daping, Yuzhong District, China, 400042

Recruiting
6,254 miles (10,064 km)  awayfrom
Canada
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Gastroenterology

Daping, Yuzhong District, China, 400042

Recruiting
6,254 miles (10,064 km)  awayfrom
Canada
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Gastroenterology

China, Fujian Sheng, Fuzhou Shi, Jinan Qu, 西庄路

Recruiting
6,199 miles (9,977 km)  awayfrom
Canada
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Gastroenterology

China, Fujian Sheng, Xiamen Shi, Siming Qu, 世贸二期5-7层

Recruiting
6,334 miles (10,193 km)  awayfrom
Canada
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Gastroenterology

Xiangcheng District, Zhangzhou, Zhangzhou, China, 363000

Recruiting
6,342 miles (10,206 km)  awayfrom
Canada
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Gastroenterology

34号之6 Zhanxi Rd N St, San Yuan Li, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, China

Recruiting
6,533 miles (10,514 km)  awayfrom
Canada
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Gastroenterology

34号之6 Zhanxi Rd N St, San Yuan Li, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, China

Recruiting
6,533 miles (10,514 km)  awayfrom
Canada
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Gastroenterology

34号之6 Zhanxi Rd N St, San Yuan Li, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, China

Recruiting
6,533 miles (10,514 km)  awayfrom
Canada
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Gastroenterology

34号之6 Zhanxi Rd N St, San Yuan Li, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, China

Recruiting
6,533 miles (10,514 km)  awayfrom
Canada
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Gastroenterology

Wuchang District, Wuhan, China, 430060

Recruiting
6,034 miles (9,710 km)  awayfrom
Canada
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Gastroenterology

Wuchang District, Wuhan, China, 430060

Recruiting
6,034 miles (9,710 km)  awayfrom
Canada
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Gastroenterology

Wuchang District, Wuhan, China, 430060

Recruiting
6,034 miles (9,710 km)  awayfrom
Canada
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Gastroenterology

Yuelu District, Changsha, China, 410013

Recruiting
6,212 miles (9,997 km)  awayfrom
Canada
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Gastroenterology

Yuelu District, Changsha, China, 410013

Recruiting
6,212 miles (9,997 km)  awayfrom
Canada
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Gastroenterology

Yuelu District, Changsha, China, 410013

Recruiting
6,212 miles (9,997 km)  awayfrom
Canada
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Gastroenterology

Gulou, Nanjing, China, 210029

Recruiting
5,837 miles (9,394 km)  awayfrom
Canada
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Gastroenterology

Gulou, Nanjing, China, 210029

Recruiting
5,837 miles (9,394 km)  awayfrom
Canada
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Gastroenterology

Qinye Rd, Zhonglou Qu, Changzhou Shi, Jiangsu Sheng, China

Recruiting
5,826 miles (9,376 km)  awayfrom
Canada
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Gastroenterology

Donghu District, Nanchang, China, 330006

Recruiting
6,116 miles (9,843 km)  awayfrom
Canada
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Gastroenterology

Chongqing Road, Chaoyang District, Changchun, Changchun, China, 130000

Recruiting
4,945 miles (7,958 km)  awayfrom
Canada
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Gastroenterology

Tiexi, Shenyang, China, 110022

Recruiting
5,120 miles (8,240 km)  awayfrom
Canada
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Gastroenterology

Xingqing District, Yinchuan, China, 750004

Recruiting
5,670 miles (9,125 km)  awayfrom
Canada
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Gastroenterology

Wujiaochang, Yangpu District, Shanghai, China

Recruiting
5,818 miles (9,364 km)  awayfrom
Canada
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Gastroenterology

Wujiaochang, Yangpu District, Shanghai, China

Recruiting
5,818 miles (9,364 km)  awayfrom
Canada
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Gastroenterology

Wujiaochang, Yangpu District, Shanghai, China

Recruiting
5,818 miles (9,364 km)  awayfrom
Canada
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Gastroenterology

Wujiaochang, Yangpu District, Shanghai, China

Recruiting
5,818 miles (9,364 km)  awayfrom
Canada
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Gastroenterology

Hongpailou, Wuhou District, Chengdu, China, 610041

Recruiting
6,225 miles (10,018 km)  awayfrom
Canada
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Gastroenterology

Wuhua District, Kunming, China, 650032

Recruiting
6,619 miles (10,653 km)  awayfrom
Canada
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Gastroenterology

New Town Shangquan, Jianggan District, Hangzhou, China, 310016

Recruiting
5,916 miles (9,522 km)  awayfrom
Canada
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Gastroenterology

New Town Shangquan, Jianggan District, Hangzhou, China, 310016

Recruiting
5,916 miles (9,522 km)  awayfrom
Canada
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Gastroenterology

Longhu District, Shantou, China, 515041

Completed
6,438 miles (10,360 km)  awayfrom
Canada
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View all (34)
Trial Protocol ID: Vedolizumab-3033
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