Ulcerative ColitisNCT05428345
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
An observational study of Ulcerative Colitis and Crohn's Disease, run by Takeda at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease (IBD)
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2023to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll participant 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.
Who may be able to join
- 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
Who cannot join
- With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
- With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
- For whom vedolizumab SC is contraindicated as per product label
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
Site Contact, 010-2533-6288, drlimyj@gmail.com
Yoon-Jung Lim, Prof.
About this study
Official title: Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
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.
Read the detailed description
This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.
This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:
- Participants with UC or CD
This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
- Keywords
- Drug Therapy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With UC or CD | Participants diagnosed 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 and have initiated treatment with vedolizumab in a routine clinical practical setting in South Korea, will be observed prospectively for 52 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serious Adverse Events (SAEs)
Measured: Up to Week 52
Percentage of Participants With Adverse Drug Reactions (ADRs)
Measured: Up to Week 52
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
Measured: Up to Week 52
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Measured: Up to Week 52
Percentage of Participants With Unexpected Adverse Events (AEs)
Measured: Up to Week 52
Percentage of Participants With Unexpected ADRs
Measured: Up to Week 52
Secondary outcomes (3)
Percentage of Participants With UC and CD Who Achieved Clinical Response
Clinical response:reduction of Mayo score of greater than or equal to(>=)3points and >=30 percent(%) from baseline score, with an accompanying decrease in rectal bleeding subscore >=1 point/an absolute rectal bleeding sub-score of less than or equal to(<=)1 point in UC participants;and reduction of Crohn's Disease Activity Index (CDAI) score >=70 points from baseline score in CD participants. Total Mayo score measures disease activity of UC;comprise of 4 sections: stool frequency,rectal bleeding,physician rating of disease activity,endoscopic findings. Each graded from 0-3. Total scores range from 0-12.Higher scores indicate more severity.CDAI assesses CD based on clinical signs such as number of liquid stools,abdominal pain,general wellbeing,presence of complications,opiates for diarrhea,presence of abdominal mass, hematocrit. CDAI consist of eight factors,each summed after adjustment with a weighting factor. Total score ranged from 0-600 points.Higher scores indicate more severity.
Measured: Up to Week 52
Percentage of Participants With UC and CD Who Achieved Clinical Remission
Clinical remission is defined as: total Mayo score <=2 and no individual sub-score greater than (>) 1 point in UC participants; and CDAI score less than (<) 150 points in CD participants. Total Mayo score measures disease activity of UC; comprise of 4 sections: stool frequency, rectal bleeding, physician rating of disease activity, endoscopic findings. Each graded from 0-3. Total scores range from 0-12. Higher scores indicate more severity. CDAI assesses CD based on clinical signs such as number of liquid stools, abdominal pain, general wellbeing, presence of complications, opiates for diarrhea, presence of abdominal mass, hematocrit. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranged from 0-600 points. Higher scores indicate more severity.
Measured: Up to Week 52
Percentage of Participants With UC and CD Who Achieved Mucosal Healing
Mucosal healing is defined as: Mayo endoscopic sub-score of <=1 point in the UC participants; and Crohn's Disease Endoscopic Index of Severity (CDEIS) score <3.5 points in the CD participants. Mayo score: instrument to measure disease activity of UC; consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, and endoscopic findings. Each graded from 0-3. Total score range of 0-12. Higher scores indicating more severity. CDEIS comprise of 4 sections assessing endoscopic severity of CD in 5 segments: rectum; sigmoid and left colon; transverse colon; right colon; ileum in terms of: deep ulcerations, superficial ulcerations, surface involved by disease and ulcerated surface measured. The presence of ulcerate and non-ulcerated stenosis will be recorded in each segment. CDEIS score range from 0-44 with a higher score indicating greater severity of disease.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start25 Sep 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428345
- Sponsor's protocol ID
- VedolizumabSC-4003
- Status last verified
- Sep 2025
- First submitted
- 16 Jun 2022
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- VedolizumabSC-4003
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.
This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:
- Participants with UC or CD
This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With UC or CD | – | –Participants diagnosed 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 and have initiated treatment with vedolizumab in a routine clinical practical setting in South Korea, will be observed prospectively for 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll participant 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
- With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
- For whom vedolizumab SC is contraindicated as per product label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 52
Percentage of Participants With Adverse Drug Reactions (ADRs)
Time frame: Up to Week 52
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
Time frame: Up to Week 52
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to Week 52
Percentage of Participants With Unexpected Adverse Events (AEs)
Time frame: Up to Week 52
Percentage of Participants With Unexpected ADRs
Time frame: Up to Week 52
3 secondary outcomes
Percentage of Participants With UC and CD Who Achieved Clinical Response
Time frame: Up to Week 52
Percentage of Participants With UC and CD Who Achieved Clinical Remission
Time frame: Up to Week 52
Percentage of Participants With UC and CD Who Achieved Mucosal Healing
Time frame: Up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by Takeda at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Serious Adverse Events (SAEs) (time frame: Up to Week 52). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.