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Moderately to Severely Active Ulcerative ColitisPhase 3NCT03221036

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

A Phase 3 study testing Vedolizumab IV in people with Moderately to Severely Active Ulcerative Colitis, run by Takeda at 36 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Vedolizumab IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
36 sitesChina
Study dates
3 Aug 2017to 30 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

China36 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Affiliated Hospital of Nanchang University

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • The First Hospital of Jilin University

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Second Affiliated Hospital of Army Medical University, PLA

    Chongqing, Chongqing Municipality, 400037

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

    Chongqing, Chongqing Municipality, 400042

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

    Fuzhou, Fujian, 350025

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

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

    Hangzhou, Zhejiang, 310016

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Nanchang University

    Shanghai, Shanghai Municipality, 100730

  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200020

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Shanghai, Shanghai Municipality, 200072

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030012

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Renmin Hospital, Wuhan University

    Wuhan, Hubei, 430060

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000

Other trials in China

About this study

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).

Read the detailed description

The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion. This study will investigate the efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants with moderately to severely active ulcerative colitis (UC).

The study will enroll approximately 302 moderately to severely active patients with ulcerative colitis.

The Induction Phase contained 2 cohorts of participants: Cohort 1 participants will be randomized 1:2 in a double-blinded manner to receive:

  • Vedolizumab IV 300 mg
  • Placebo IV

Cohort 2 participants will be treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis.

Participants will receive induction therapy of Vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6. At Week 10, participants will be assessed for clinical response based on complete clinic Mayo score. Results of Week 10 clinical response will determine the treatment pathway in maintenance phase.

In the Maintenance Phase, participants who received vedolizumab in the induction phase and achieved clinical response at Week 10 will be randomized 1:1 in a double-blinded manner to receive vedolizumab IV 300 mg or placebo starting from Week 14 (i.e., Weeks 14, 22, 30, 38, 46, and 54).

This multi-center trial will be conducted in China. The overall time to participate in this study is 60 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of investigational product (IP) for a long term follow-up safety survey.

Being tested
Vedolizumab IV, Placebo
Keywords
Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vedolizumab IVDrug

    Vedolizumab IV infusion

  • PlaceboDrug

    Matching-placebo IV infusion

Study groups in NCT03221036
Study groupRoleWhat they receive
Induction Phase: Vedolizumab 300 mgExperimentalVedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, and 6 during induction phase.
Receives: Drug: Vedolizumab IV
Induction Phase: PlaceboPlacebo comparatorMatching placebo IV infusion at Weeks 0, 2, and 6 during induction phase.
Receives: Drug: Placebo
Maintenance Phase: Vedolizumab 300 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab IV
Maintenance Phase: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 10

  2. 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.

    Measured: Week 60

Secondary outcomes (5)

  1. Induction Phase: 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.

    Measured: Week 10

  2. Induction and Maintenance Phase: 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.

    Measured: Weeks 10 and 60

  3. Maintenance Phase: 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.

    Measured: Weeks 10 and 60

  4. Maintenance Phase: 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.

    Measured: Weeks 10 and 60

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

    Measured: Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start3 Aug 2017
  3. Primary completion24 Sep 2027 (estimated)
  4. Study completion30 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03221036
Sponsor's protocol ID
Vedolizumab-3033
Other IDs
U1111-1195-3994
Status last verified
May 2026
First submitted
14 Jul 2017
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab IV in people with Moderately to Severely Active Ulcerative Colitis, run by Takeda at 36 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction Phase: Percentage of Participants with Clinical Response at Week 10 (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03221036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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