A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
NCT ID: NCT05837897
Last Updated: 2025-11-05
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
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RECRUITING
PHASE3
408 participants
INTERVENTIONAL
2023-06-16
2031-05-30
Brief Summary
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Detailed Description
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The study will enroll approximately 408 patients. Participants will be randomized into 2:1 in the Induction Period to receive:
* Vedolizumab IV 300 mg
* Placebo
All participants completing the Week 14 visit, irrespective of their response status, will continue in the OLE without unblinding of their baseline treatment group and will receive 300 mg vedolizumab once every 8 weeks (Q8W) starting from Week 14. Starting at Week 18 and throughout the remainder of the OLE, participants who are nonresponders or who have disease worsening based on the assessment by visit every 4 weeks, are eligible to receive 300 mg vedolizumab once every 4 weeks (Q4W).
This multi-center trial will be conducted in China. The overall time participants will be in this study is approximately 58 weeks. Participants will make a final safety follow-up visit at 18 weeks after the last dose of study drug. Participants will also be followed-up for a long-term follow-up safety survey after completion of or early termination from study via telephone, 6 months after last dose of study drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Induction Period: Vedolizumab 300 mg
Participants will receive vedolizumab 300 mg IV infusion on Days 1,15, and 43 (Weeks 0, 2, and 6) in the 14-week Induction Period.
Vedolizumab IV
Vedolizumab IV infusion
Induction Period: Placebo
Participants will receive vedolizumab placebo-matching IV, infusion on Days 1,15, and 43 (Weeks 0, 2, and 6) in the 14-week Induction Period.
Placebo
Vedolizumab placebo-matching IV infusion
Open-label Extension (OLE) Period: Vedolizumab 300 mg
All participants completing the Week 14 visit, irrespective of their response status, will continue in the OLE without unblinding of their baseline treatment group and will receive vedolizumab 300 mg, IV infusion, Q8W, on Days 99, 155, 211, 267, 323, and 379 (Weeks 14, 22, 30, 38, 46 and 54). Starting from Day 127 (Week 18) until the end of OLE Period up to approximately 58 weeks, participants who are nonresponders or who have disease worsening are eligible to receive 300 mg vedolizumab Q4W.
Vedolizumab IV
Vedolizumab IV infusion
Interventions
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Placebo
Vedolizumab placebo-matching IV infusion
Vedolizumab IV
Vedolizumab IV infusion
Eligibility Criteria
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Inclusion Criteria
2. The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy.
3. The participant has CD involvement of the ileum and/or colon, at a minimum.
4. A participant with extensive colitis or pancolitis of \>8 years duration or limited colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before initial screening (may be performed during screening if not performed in previous 12 months).
5. A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).
6. The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
* Corticosteroids.
* Immunomodulators.
* TNF-α antagonists.
Exclusion Criteria
2. The participant has had extensive colonic resection, subtotal or total colectomy.
3. The participant has a history of \>3 small bowel resections or diagnosis of short bowel syndrome.
4. The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug.
5. The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
6. Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease:
* Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section.
* An approved or investigational nonbiologic therapy in an investigational protocol.
7. The participant has received traditional Chinese medication (TCMs) within 30 days before randomization.
8. The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) antagonists, or rituximab.
9. The participant has had previous exposure to vedolizumab.
10. The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the first dose of study drug.
11. The participant requires currently or is anticipated to require surgical intervention for CD during the study.
12. The participant has a history or evidence of adenomatous colonic polyps that have not been removed.
13. The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.
14. The participant has evidence of active infection during the screening period.
15. The participant has evidence of treatment for Clostridioides difficile (C difficile) infection or other intestinal pathogen within, 28 days before first dose of study drug.
16. The participant has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
17. The participant has active or latent tuberculosis (TB).
18. The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
19. The participants has received any live vaccinations within 30 days before screening.
20. The participant has a clinically significant active infection (eg, pneumonia, pyelonephritis, or coronavirus disease 2019 \[COVID-19\]) within 30 days before screening or during screening, or has an ongoing chronic infection or any ongoing COVID-19-related symptom(s), if previously diagnosed as having COVID-19.
21. The participant has had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period.
22. The participant has any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and has not recurred for at least 1 year before randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and has not recurred for at least 3 years before randomization. Participants 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 before randomization.
23. The participant has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
18 Years
80 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking University First Hospital - Changqiao Campus
Beijing, Beijing Municipality, China
People's Hospital of Ningxia Hui Aotonomous Region
Yinchuan, Ningxia, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital - Main
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University - Main
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, China
The 2nd Affliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Nanyang First People's Hospital
Nanyang, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University - Main Campus
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Changzhou No.2 People's Hospital - Yanling Campus
Changzhou, Jiangsu, China
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China
Changshu No.2 People's Hospital
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University - Nanhu Campus
Shenyang, Liaoning, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University - Fangqiao Campus
Ningbo, Zhejiang, China
People's Hospital of Quzhou
Quzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province - Main
Taizhou, Zhejiang, China
The First People's Hospital of Wenling
Taizhou, Zhejiang, China
The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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Vedolizumab-3040
Identifier Type: -
Identifier Source: org_study_id
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