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NCT04799496

A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

688 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2025-06-30

Brief Summary

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In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.

The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

Detailed Description

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This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for UC, and have had an inadequate response with, or lost response to antibiotic therapy. This study will evaluate the safety and effectiveness of Kynteles injection (Vedolizumab) in a routine clinical practice setting under real world conditions.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs).

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Conditions

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Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases

Keywords

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Drug Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kynteles Injection (Vedolizumab)

Participants 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 tumor necrosis factor-alpha (TNF-α) antagonist or participants with pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy and have initiated Kynteles injection (Vedolizumab) treatment in a routine clinical practical setting in South Korea, will be observed prospectively.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

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South Korea

Other Identifiers

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Vedolizumab-4023

Identifier Type: -

Identifier Source: org_study_id

A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Kynteles Injection (Vedolizumab)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Takeda

Responsible Party

Principal Investigators

Study Director

Locations

Soon Chunhyang University Hospital Bucheon

Inje University Busan Paik Hospital

Inje University Haeundae Paik Hospital

Good Gang-An Hospital

Dong-A University Hospital

Pusan National University Hospital

Kosin University Gospel Hospital

Soonchunhyang University Cheonan Hospital

Chungbuk National University Hospital

Hallym Univ. Medical Center

Kangwon National University Hospital

Daegu Patima Hospital

Kyungpook National University Chilgok Hospital

Kyungpook National University Hospital

Yeungnam University Medical Center

Keimyung University Dongsan Hospital

Koo Hospital

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

Chosun University Hospital

Inje University Ilsan Paik Hospital

Hanyang University Medical Center

The Catholic University of Korea, Bucheon ST. Marys Hospital

Korea University Ansan Hospital

DongGuk University International Hospital

Ilsan Paik Hospital

Jeonbuk National University Hospital

CHA University Bundang Medical Center

Seoul National University Bundang Hospital

Inje University Sanggye Paik Hospital

Nowon Eulji Medical Center, Eulji University

KyungHee University Hospital

Seoul National University Hospital

Kangbuk Samsung Hospital

Severance Hospital

Kyunghee University Hospital at Gangdong

Asan Medical Center

Gangnam Severance Hospital

Samsung Medical Center

Seoul St.Mary's Hospital

Chung-Ang University Hospital

Ulsan university Hospital

Wonju Severance Christian Hospital

Pusan National University Yangsan Hospital

Countries

Related Links

Other Identifiers

Vedolizumab-4023