RecruitingPhase 3NCT03221036

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

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

Sponsor

Takeda

Enrollment

402 participants

Start Date

Aug 3, 2017

Study Type

INTERVENTIONAL

Conditions

Moderately to Severely Active Ulcerative Colitis

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether vedolizumab (an IV infusion medication that targets the gut immune system) is safe and effective for treating ulcerative colitis (UC, a condition causing chronic inflammation and sores in the large intestine) in patients in China. **You may be eligible if...** - You have had a confirmed diagnosis of ulcerative colitis for at least 3 months, supported by a colonoscopy and biopsy report - Your disease is moderately to severely active despite prior treatment - You have not adequately responded to or cannot tolerate other UC medications **You may NOT be eligible if...** - You were diagnosed with UC less than 3 months ago - Your UC is in remission or only mildly active - You have an active serious infection - You have conditions that make this medication unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVedolizumab IV

Vedolizumab IV infusion

DRUGPlacebo

Matching-placebo IV infusion

Locations(36)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Nanchang University

Beijing, Beijing Municipality, China

Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, China

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

Chongqing, Chongqing Municipality, China

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

Fuzhou, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Renmin Hospital, Wuhan University

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Hospital of Jilin University

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The First Affiliated Hospital of Nanchang University

Shanghai, Shanghai Municipality, China

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Shanghai, Shanghai Municipality, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03221036

Related Trials

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

NCT071582429 locations

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

NCT06588855198 locations

A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis

NCT070350411 location