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Real-World study confirms kynteles safety for IBD patients

NCT ID NCT04799496

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study monitored 688 people in South Korea with ulcerative colitis, Crohn's disease, or pouchitis who were treated with Kynteles (vedolizumab) as part of their normal care. The main goal was to track side effects, and researchers also looked at how many patients saw symptom improvement. The results help confirm the drug's safety and effectiveness in everyday practice.

What this could mean

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

Active substance
Vedolizumab (Kynteles injection)
What this could lead to
If successful, this study confirms vedolizumab is safe and effective for managing ulcerative colitis, Crohn's disease, and pouchitis in routine care.
What could go wrong
This is a post-marketing surveillance study, not a new treatment test. It only observes real-world use, so it won't prove new benefits or cures.

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.

Participants

688 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2025

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.

Who is studied

This study will enroll moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist or pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Ages

18 years and older

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. With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist 2. With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy. Exclusion Criteria: 1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients 2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML) 3. Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease pouchitis ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative Crohn disease Inflammatory bowel diseases

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • CHA University Bundang Medical Center

    Seongnam, 13496, South Korea

  • Chosun University Hospital

    Gwangju, 61453, South Korea

  • Chung-Ang University Hospital

    Seoul, 06973, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Daegu Patima Hospital

    Daegu, 41199, South Korea

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • DongGuk University International Hospital

    Ilsan, 10326, South Korea

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Good Gang-An Hospital

    Busan, 48265, South Korea

  • Hallym Univ. Medical Center

    Chuncheon, 24253, South Korea

  • Hanyang University Medical Center

    Gyeonggi-do, 11923, South Korea

  • Ilsan Paik Hospital

    Ilsan, 10380, South Korea

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Inje University Ilsan Paik Hospital

    Gyeonggi-do, 10380, South Korea

  • Inje University Sanggye Paik Hospital

    Seoul, 01757, South Korea

  • Jeonbuk National University Hospital

    Jeonju, 54907, South Korea

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kangwon National University Hospital

    Chuncheon, 24289, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Koo Hospital

    Daegu, 42644, South Korea

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355, South Korea

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • KyungHee University Hospital

    Seoul, 02447, South Korea

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Kyungpook National University Hospital

    Daegu, 41404, South Korea

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830, South Korea

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St.Mary's Hospital

    Seoul, 06591, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Soon Chunhyang University Hospital Bucheon

    Bucheon-si, 14584, South Korea

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151, South Korea

  • The Catholic University of Korea, Bucheon ST. Marys Hospital

    Gyeonggi-do, 14647, South Korea

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    Daejeon, 34943, South Korea

  • Ulsan university Hospital

    Ulsan, 44033, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, 26426, South Korea

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

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