New hope for chinese ulcerative colitis patients: vedolizumab trial shows promise

NCT ID NCT03221036

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether vedolizumab, given as an IV infusion, can help Chinese adults with moderate to severe ulcerative colitis. About 392 participants will receive either the drug or a placebo. The goal is to see if it reduces symptoms like diarrhea and bleeding, and helps achieve long-term remission over 60 weeks.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

392 people

The number who actually took part.

Started

Aug 2017

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Cases of UC established at least 6 months before randomization for which a histopathology report is not available will be considered based on the weight of evidence supporting the diagnosis and excluding other potential diagnoses and must be discussed with the sponsor on a case-by case basis before randomization. 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 IP. 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 (for example, natalizumab, efalizumab, etrolizumab, or AMG-181) or mucosal address in 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 IP. 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 (for example, 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 (for example, \>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 IP at Week 0.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderately to severely active ulcerative colitis

Contacts and locations

Locations

Army Specialty Medical Center of The Chinese People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China
Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China
First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China
General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China
Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China
Meizhou People's Hospital

Meizhou, Guangdong, 514031, China
Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China
Renmin Hospital, Wuhan University

Wuhan, Hubei, 430060, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China
Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, 400037, China
Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110022, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310016, China
The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force

Fuzhou, Fujian, 350025, China
The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China
The First Affiliated Hospital of Nanchang University

Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University

Shanghai, Shanghai Municipality, 100730, China
The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China
The First Hospital of Jilin University

Changsha, Hunan, 410011, China
The First Hospital of Jilin University

Changchun, Jilin, 130021, China
The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China
The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China
The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China
The Sixth Affiliated Hospital of Sun Yat-sen University

Shanghai, Shanghai Municipality, 200072, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China
West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China
Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China
Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China
Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, 363000, China
Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

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