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New hope for Crohn's: drug trial aims to tame gut inflammation

NCT ID NCT05837897

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests the drug vedolizumab in 408 adults in China with moderate-to-severe Crohn's disease. Participants receive IV infusions of vedolizumab or a placebo over several weeks. The goal is to see if vedolizumab can reduce symptoms like abdominal pain and diarrhea, and help achieve remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vedolizumab
What this could lead to
If successful, this could provide a new treatment option for people in China with moderate-to-severe Crohn's disease to control symptoms and improve quality of life.
What could go wrong
This is a late-stage trial, but results may not apply to all patients. Vedolizumab may not work for everyone and can have side effects like infections or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 408 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD 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. The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy. 3. The participant has CD involvement of the ileum and/or colon, at a minimum. 4. A participant with extensive colitis or pancolitis of \>8 years duration or limited colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before initial screening (may be performed during screening if not performed in previous 12 months). 5. A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening). 6. The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below: * Corticosteroids. * Immunomodulators. * TNF-α antagonists. Exclusion Criteria: I. Gastrointestinal (GI) Exclusion Criteria: 1. The participant has evidence of abdominal abscess at the initial screening visit. 2. The participant has had extensive colonic resection, subtotal or total colectomy. 3. The participant has a history of \>3 small bowel resections or diagnosis of short bowel syndrome. 4. The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug. 5. The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation. 6. Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease: * Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section. * An approved or investigational nonbiologic therapy in an investigational protocol. 7. The participant has received traditional Chinese medication (TCMs) within 30 days before randomization. 8. The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) antagonists, or rituximab. 9. The participant has had previous exposure to vedolizumab. 10. The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the first dose of study drug. 11. The participant requires currently or is anticipated to require surgical intervention for CD during the study. 12. The participant has a history or evidence of adenomatous colonic polyps that have not been removed. 13. The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia. II. Infectious Disease Exclusion Criteria 14. The participant has evidence of active infection during the screening period. 15. The participant has evidence of treatment for Clostridioides difficile (C difficile) infection or other intestinal pathogen within, 28 days before first dose of study drug. 16. The participant has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection. 17. The participant has active or latent tuberculosis (TB). 18. The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation). 19. The participants has received any live vaccinations within 30 days before screening. 20. The participant has a clinically significant active infection (eg, pneumonia, pyelonephritis, or coronavirus disease 2019 \[COVID-19\]) within 30 days before screening or during screening, or has an ongoing chronic infection or any ongoing COVID-19-related symptom(s), if previously diagnosed as having COVID-19. III. General Exclusion Criteria 21. The participant has had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period. 22. The participant has any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and has not recurred for at least 1 year before randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and has not recurred for at least 3 years before randomization. Participants 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 before randomization. 23. The participant has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Changshu No.2 People's Hospital

    RECRUITING

    Suzhou, Jiangsu, 215516, China

  • Changzhou No.2 People's Hospital - Yanling Campus

    RECRUITING

    Changzhou, Jiangsu, 213200, China

  • Guangzhou First People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Huizhou Central People's Hospital

    RECRUITING

    Huizhou, Guangdong, 516001, China

  • Lanzhou University Second Hospital

    RECRUITING

    Lanzhou, Gansu, 730030, China

  • Nanyang First People's Hospital

    RECRUITING

    Nanyang, Henan, 474500, China

  • Peking University First Hospital - Changqiao Campus

    COMPLETED

    Beijing, Beijing Municipality, 100034, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • People's Hospital of Ningxia Hui Aotonomous Region

    COMPLETED

    Yinchuan, Ningxia, 750002, China

  • People's Hospital of Quzhou

    COMPLETED

    Quzhou, Zhejiang, 324307, China

  • Qingyuan People's Hospital

    COMPLETED

    Qingyuan, Guangdong, 511518, China

  • Renmin Hospital of Wuhan University - Main Campus

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Shanghai Changhai Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shanghai East Hospital - Main

    RECRUITING

    Shanghai, Shanghai Municipality, 200123, China

  • Shengjing Hospital of China Medical University - Nanhu Campus

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • Taizhou Hospital of Zhejiang Province - Main

    RECRUITING

    Taizhou, Zhejiang, 317000, China

  • The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus

    COMPLETED

    Wenzhou, Zhejiang, 325000, China

  • The 2nd Affliated Hospital of Harbin Medical University

    RECRUITING

    Haerbin, Heilongjiang, 150081, China

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    RECRUITING

    Zhuhai, Guangdong, 519000, China

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Ningbo University - Fangqiao Campus

    RECRUITING

    Ningbo, Zhejiang, 315010, China

  • The First Affiliated Hospital, Sun Yat-sen University - Main

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First People's Hospital of Foshan

    RECRUITING

    Foshan, Guangdong, 528000, China

  • The First People's Hospital of Wenling

    RECRUITING

    Taizhou, Zhejiang, 317599, China

  • The First People's Hospital of Yunnan Province

    RECRUITING

    Kunming, Yunnan, 650100, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510260, China

  • The Second Affiliated Hospital of Nanchang University - Donghu Campus

    RECRUITING

    Nanchang, Jiangxi, 330008, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • The Second Hospital of Hebei Medical University - Main

    COMPLETED

    Shijiazhuang, Hebei, 50051, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

  • The Third Affiliated Hospital, Sun Yat-Sen University

    COMPLETED

    Guangzhou, Guangdong, 510630, China

  • The University of Hong Kong - Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518053, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300052, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xuzhou Central Hospital

    COMPLETED

    Xuzhou, Jiangsu, 221009, China

  • Yantai Yuhuangding Hospital

    COMPLETED

    Yantai, Shandong, 264000, China

  • Yijishan Hospital of Wannan Medical College

    RECRUITING

    Wuhu, Anhui, 241001, China

  • Zhongda Hospital, Affiliated to Southeast University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Zhongshan Hospital Fudan University

    COMPLETED

    Shanghai, Shanghai Municipality, 200022, China

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