NCT05428345 A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
| NCT ID | NCT05428345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Takeda |
| Condition | Ulcerative Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-09-25 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-09-25 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.
Eligibility Criteria
Inclusion Criteria: 1. With moderately to severely active UC or 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 evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions Exclusion Criteria: 1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance 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. For whom vedolizumab SC is contraindicated as per product label
Contact & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT05428345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05428345 currently recruiting?
Yes, NCT05428345 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT05428345 trial being conducted?
This trial is being conducted at Goyang-si, South Korea.
Who is sponsoring the NCT05428345 clinical trial?
NCT05428345 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 600 participants.
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