Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

NCT03221036 | Recruiting Phase 3

• 2 other identifiers: Vedolizumab-3033U1111-1195-3994
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 36

Brief Summary

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).

Conditions

Moderately to Severely Active Ulcerative Colitis

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• Induction Phase: 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

• Maintenance Phase: 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 Outcomes (5)

• Induction Phase: Percentage of Participants with Clinical Remission at Week 10

  Week 10

• Induction and Maintenance Phase: Percentage of Participants with Mucosal Healing at Weeks 10 and 60

  Weeks 10 and 60

• Maintenance Phase: Percentage of Participants with Durable Clinical Response at Weeks 10 and 60

  Weeks 10 and 60

• Maintenance Phase: Percentage of Participants with Durable Clinical Remission at Weeks 10 and 60

  Weeks 10 and 60

• Maintenance Phase: Percentage of Participants Using Oral Corticosteroids at Baseline who have Discontinued Corticosteroids and are in Clinical Remission at Week 60

  Week 60

Study Arms (4)

Induction Phase: Vedolizumab 300 mg

EXPERIMENTAL

Vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, and 6 during induction phase.

Drug: Vedolizumab IV

Induction Phase: Placebo

PLACEBO COMPARATOR

Matching placebo IV infusion at Weeks 0, 2, and 6 during induction phase.

Drug: Placebo

Maintenance Phase: Vedolizumab 300 mg

EXPERIMENTAL

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.

Drug: Vedolizumab IV

Maintenance Phase: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Vedolizumab IV DRUG

Vedolizumab IV infusion

Induction Phase: Vedolizumab 300 mg; Maintenance Phase: Vedolizumab 300 mg

Placebo DRUG

Matching-placebo IV infusion

Induction Phase: Placebo; Maintenance Phase: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Has evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
• 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).
• 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).
• 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.

You may not qualify if:

• Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
• Has had extensive colonic resection, subtotal or total colectomy.
• 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.
• 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.
• 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.
• Currently requires or is anticipated to require surgical intervention for UC during the study.
• 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.
• Has a suspected or confirmed diagnosis of Crohn's enterocolitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
• Has evidence of or has had treatment for C. difficile infection or other intestinal pathogen within 28 days prior to randomization.
• Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
• Has active or latent TB.
• Has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
• 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.
• Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (36)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

COMPLETED

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

COMPLETED

The First Affiliated Hospital of Nanchang University

Beijing, Beijing Municipality, 100730, China

COMPLETED

Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, 400037, China

COMPLETED

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

Chongqing, Chongqing Municipality, 400042, China

COMPLETED

The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force

Fuzhou, Fujian, 350025, China

COMPLETED

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

RECRUITING

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, 363000, China

COMPLETED

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

COMPLETED

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

COMPLETED

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

COMPLETED

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

COMPLETED

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Renmin Hospital, Wuhan University

Wuhan, Hubei, 430060, China

COMPLETED

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

The First Hospital of Jilin University

Changsha, Hunan, 410011, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

COMPLETED

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

COMPLETED

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

COMPLETED

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

COMPLETED

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110022, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

COMPLETED

The First Affiliated Hospital of Nanchang University

Shanghai, Shanghai Municipality, 100730, China

COMPLETED

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

COMPLETED

The Sixth Affiliated Hospital of Sun Yat-sen University

Shanghai, Shanghai Municipality, 200072, China

COMPLETED

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

COMPLETED

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

COMPLETED

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310016, China

COMPLETED

Related Links

• 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.

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Study Registration Call Center

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: August 3, 2017
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (36)