A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Observational · No treatment assigned · 1 site · Takeda
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis, Crohn's Disease and Inflammatory Bowel Disease (IBD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
- With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 600 participants are expected to take part.
- Start date: 2023-09-25.
- Main results expected around 2027-11-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in South Korea.
Main thing being measured
- Percentage of Participants With Serious Adverse Events (SAEs) (Up to Week 52)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Disease (IBD) |
| Lead sponsor | Takeda |
| Enrollment | 600 (estimated) |
| Start date | 2023-09-25 |
| Primary completion (est.) | 2027-11-30 |
| First posted | 2022-06-23 |
| Last updated | 2025-10-06 |
| Official title | Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea |
| ClinicalTrials.gov ID | NCT05428345 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Donggguk University Ilsan Hospital | Goyang-si, Gyeonggi-do | South Korea | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.