Moderately to Severely Active Ulcerative Colitis Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative Colitis
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).
| Status | Recruiting |
| Enrollment | 402 |
| Est. completion date | July 18, 2028 |
| Est. primary completion date | May 23, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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-a) 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Gastroenterology | Beijing | Beijing |
| China | Gastroenterology | Beijing | Beijing |
| China | Gastroenterology | Changchun | Jilin |
| China | Gastroenterology | Changsha | Hunan |
| China | Gastroenterology | Changsha | Hunan |
| China | Gastroenterology | Changsha | Hunan |
| China | Gastroenterology | Chengdu | Sichuan |
| China | Gastroenterology | Chongqing | Chongqing Sichuan |
| China | Gastroenterology | Chongqing | Chongqing |
| China | Gastroenterology | Fuzhou | Fujian |
| China | Gastroenterology | Guangzhou | Guangdong |
| China | Gastroenterology | Guangzhou | Guangdong |
| China | Gastroenterology | Guangzhou | Guangdong |
| China | Gastroenterology | Guangzhou | Guangdong |
| China | Gastroenterology | Hangzhou | Zhejiang |
| China | Gastroenterology | Hangzhou | Zhejiang |
| China | Gastroenterology | Hefei | Anhui |
| China | Gastroenterology | Kunming | Yunnan |
| China | Gastroenterology | Meizhou | Guangdong |
| China | Gastroenterology | Nanchang | Jiangxi |
| China | Gastroenterology | Nanjing | Jiangsu |
| China | Gastroenterology | Nanjing | Jiangsu |
| China | Gastroenterology | Shanghai | Shanghai |
| China | Gastroenterology | Shanghai | Shanghai |
| China | Gastroenterology | Shanghai | Shanghai |
| China | Gastroenterology | Shanghai | Shanghai |
| China | Gastroenterology | Shantou | Guangdong |
| China | Gastroenterology | Shenyang | Liaoning |
| China | Gastroenterology | Shijiazhuang | Hebei |
| China | Gastroenterology | Taiyuan | Shanxi |
| China | Gastroenterology | Wuhan | Hubei |
| China | Gastroenterology | Wuhan | Hubei |
| China | Gastroenterology | Wuhan | Hubei |
| China | Gastroenterology | Wuxi | Jiangsu |
| China | Gastroenterology | Xi'an | Shanxi |
| China | Gastroenterology | Xiamen | Fujian |
| China | Gastroenterology | Yinchuan | Ningxia |
| China | Gastroenterology | Zhangzhou | Fujian |
| China | Gastroenterology | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants with Clinical Response at Week 10 | Clinical response is defined as =3 points reduction in complete Mayo clinical score and =30% decrease from baseline score accompanied with =1 point decrease in rectal bleeding subscore or absolute rectal bleeding subscore =1. Mayo clinical score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease. | Week 10 | |
| Primary | Percentage of Participants with Clinical Remission at Week 60 | Clinical remission is defined as complete Mayo clinic score =2 with no subscore >1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease. | Week 60 | |
| Secondary | Percentage of Participants with Clinical Remission at Week 10 | Clinical remission is defined as complete Mayo clinic score =2 with no subscore >1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease. | Week 10 | |
| Secondary | Percentage of Participants with Mucosal Healing at Weeks 10 and 60 | Mucosal healing is defined as Mayo endoscopic subscore =1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease. | Weeks 10 and 60 | |
| Secondary | Percentage of Participants with Durable Clinical Response at Weeks 10 and 60 | Clinical response is defined as =3 points reduction in complete Mayo clinical score and =30% decrease from baseline score accompanied with =1 point decrease in rectal bleeding subscore or absolute rectal bleeding subscore =1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease. | Weeks 10 and 60 | |
| Secondary | Percentage of Participants with Durable Clinical Remission at Weeks 10 and 60 | Clinical remission is defined as complete Mayo clinic score =2 with no subscore >1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease. | Weeks 10 and 60 | |
| Secondary | Percentage of Participants Using Oral Corticosteroids at Baseline who have Discontinued Corticosteroids and are in Clinical Remission at Week 60 | Week 60 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04176588 -
A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 |