Effect of Vedolizumab IV on Ulcerative Colitis in Chinese Patients

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

This study is testing if an intravenous medication called vedolizumab can help Chinese patients with moderate to severe ulcerative colitis feel better and stay better over time.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Drugs / interventions: natalizumab, efalizumab, etrolizumab, rituximab, radiation, vedolizumab
• Locations: 36 sites (Hefei, Anhui and 35 other locations)
• Trial ID: NCT03221036 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of vedolizumab administered intravenously as both induction and maintenance therapy for Chinese participants suffering from moderately to severely active ulcerative colitis (UC). Approximately 302 patients will be enrolled, with the induction phase involving a randomized, double-blind comparison of vedolizumab and placebo. Participants who respond to treatment will then enter a maintenance phase where they will continue receiving vedolizumab or placebo based on their initial response. The study aims to provide insights into the drug's effectiveness in this specific population.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with moderately to severely active ulcerative colitis, confirmed by clinical and endoscopic evidence.

Not a fit: Patients with mild ulcerative colitis or those who have not been diagnosed with the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis in Chinese patients.

How similar studies have performed: Previous studies have shown positive outcomes with vedolizumab in other populations, suggesting potential success in this trial.

Eligibility 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. 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.

Where this trial is running

Hefei, Anhui and 35 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Completed)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Completed)
• The First Affiliated Hospital of Nanchang University — Beijing, Beijing Municipality, China (Completed)
• Second Affiliated Hospital of Army Medical University, PLA — Chongqing, Chongqing Municipality, China (Completed)
• Army Specialty Medical Center of The Chinese People's Liberation Army — Chongqing, Chongqing Municipality, China (Completed)
• The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force — Fuzhou, Fujian, China (Completed)
• Zhongshan Hospital Xiamen University — Xiamen, Fujian, China (Recruiting)
• Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China (Completed)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Completed)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Completed)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Completed)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Meizhou People's Hospital — Meizhou, Guangdong, China (Recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Completed)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Renmin Hospital, Wuhan University — Wuhan, Hubei, China (Completed)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• The First Hospital of Jilin University — Changsha, Hunan, China (Recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Completed)
• The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Completed)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• Wuxi People's Hospital — Wuxi, Jiangsu, China (Completed)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Completed)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Completed)
• The First Affiliated Hospital of Nanchang University — Shanghai, Shanghai Municipality, China (Completed)
• Ruijin Hospital of Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Completed)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Shanghai, Shanghai Municipality, China (Completed)
• Shanxi Provincial People's Hospital — Taiyuan, Shanxi, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Completed)
• First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Completed)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (Completed)

Study contacts

• Study coordinator: Takeda Study Registration Call Center

Conditions Moderately to Severely Active Ulcerative Colitis; Drug therapy