Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis
NCT ID: NCT03221036
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
402 participants
INTERVENTIONAL
2017-08-03
2028-07-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 investigational product (IP) for a long term follow-up safety survey.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Induction Phase: Vedolizumab 300 mg
Vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, and 6 during induction phase.
Vedolizumab IV
Vedolizumab IV infusion
Induction Phase: Placebo
Matching placebo IV infusion at Weeks 0, 2, and 6 during induction phase.
Placebo
Matching-placebo IV infusion
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.
Vedolizumab IV
Vedolizumab IV infusion
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.
Placebo
Matching-placebo IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vedolizumab IV
Vedolizumab IV infusion
Placebo
Matching-placebo IV infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gastroenterology
Hefei, Anhui, China
Gastroenterology
Beijing, Beijing Municipality, China
Gastroenterology
Beijing, Beijing Municipality, China
Gastroenterology
Chongqing, Chongqing Municipality, China
Gastroenterology
Chongqing, Chongqing Sichuan, China
Gastroenterology
Fuzhou, Fujian, China
Gastroenterology
Xiamen, Fujian, China
Gastroenterology
Zhangzhou, Fujian, China
Gastroenterology
Guangzhou, Guangdong, China
Gastroenterology
Guangzhou, Guangdong, China
Gastroenterology
Guangzhou, Guangdong, China
Gastroenterology
Guangzhou, Guangdong, China
Gastroenterology
Meizhou, Guangdong, China
Gastroenterology
Shantou, Guangdong, China
Gastroenterology
Shijiazhuang, Hebei, China
Gastroenterology
Zhengzhou, Henan, China
Gastroenterology
Wuhan, Hubei, China
Gastroenterology
Wuhan, Hubei, China
Gastroenterology
Wuhan, Hubei, China
Gastroenterology
Changsha, Hunan, China
Gastroenterology
Changsha, Hunan, China
Gastroenterology
Changsha, Hunan, China
Gastroenterology
Nanjing, Jiangsu, China
Gastroenterology
Nanjing, Jiangsu, China
Gastroenterology
Wuxi, Jiangsu, China
Gastroenterology
Nanchang, Jiangxi, China
Gastroenterology
Changchun, Jilin, China
Gastroenterology
Shenyang, Liaoning, China
Gastroenterology
Yinchuan, Ningxia, China
Gastroenterology
Shanghai, Shanghai Municipality, China
Gastroenterology
Shanghai, Shanghai Municipality, China
Gastroenterology
Shanghai, Shanghai Municipality, China
Gastroenterology
Shanghai, Shanghai Municipality, China
Gastroenterology
Taiyuan, Shanxi, China
Gastroenterology
Xi’an, Shanxi, China
Gastroenterology
Chengdu, Sichuan, China
Gastroenterology
Kunming, Yunnan, China
Gastroenterology
Hangzhou, Zhejiang, China
Gastroenterology
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
To obtain more information on this study, click this link
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1195-3994
Identifier Type: OTHER
Identifier Source: secondary_id
Vedolizumab-3033
Identifier Type: -
Identifier Source: org_study_id