A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
Launched by TAKEDA · Mar 15, 2021
Trial Information
Current as of May 02, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of Kynteles injection (Vedolizumab) in adults with moderate to severe ulcerative colitis, Crohn's disease, or chronic pouchitis. The main goals are to find out how well the treatment works and to see if there are any side effects. Participants will receive the injection as part of their regular treatment plan at their clinic.
To be eligible for this study, participants must be adults aged 18 and older who have not had enough improvement from previous treatments for their condition. People with certain severe allergies to the injection or those with serious infections cannot take part in the study. If you join, you can expect regular check-ins to monitor your health and track any changes in your symptoms after receiving the treatment. Your participation will help researchers understand more about how effective Kynteles injection is for managing these inflammatory bowel diseases.
Gender
ALL
Eligibility criteria
- 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.
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Busan, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Busan, , Korea, Republic Of
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Yangsan, Gyeongnam, Korea, Republic Of
Daegu, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Busan, , Korea, Republic Of
Busan, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Wonju, , Korea, Republic Of
Cheongju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Cheonan, , Korea, Republic Of
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Chuncheon, , Korea, Republic Of
Daegu, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Bucheon, , Korea, Republic Of
Chuncheon, , Korea, Republic Of
Daegu, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Ilsan, , Korea, Republic Of
Ilsan, , Korea, Republic Of
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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