Crohn's Disease and Ulcerative ColitisPhase 3VEDOKO-IITNCT04919252
Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease
A Phase 3 study testing Vedolizumab in people with Crohn's Disease and Ulcerative Colitis, run by Yonsei University at 1 site in South Korea.
Trial summary
If subjects voluntarily consent to participation in the study, those who are finally determined to be eligible for the study after whether all of the inclusion criteria and none of the exclusion criteria are met is checked will receive the study drug. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Crohn's Disease and Ulcerative Colitis
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 19 years to ≤ 70 years
- Patients with moderate-to-severe active Crohn's disease or ulcerative colitis who are unresponsive to, become unresponsive to, or have no tolerability to universal treatment (with corticosteroids, immunomodulators, etc.)
- CDAI (Crohn's Disease Activity Index) ≥ 220 for Crohn's disease
- Complete Mayo score ≥ 6 for ulcerative colitis
Who cannot join
- A history of total colectomy
- Acute severe UC(Ulcerative Colitis)
- A potential for a bowel resection surgery within 3 months
- Pregnancy and breastfeeding
- Prior use of any biologics including anti-TNFs, ustekinumab, and tofacitinib
- A history of solid cancer and blood cancer within 5 years
Show all 14Show fewer
- Positive for active or latent tuberculosis (However, screening is possible if active tuberculosis is excluded and after at least 4 weeks of latent tuberculosis treatment.)
- Active severe infections such as sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
- Hypersensitivity to vedolizumab or its substances (e.g., dyspnoea, bronchospasm, redness, and increased heart rate)
- Experience of treatment with a drug or a medical device due to participation in another clinical trial within 3 months from the date of consent
- A woman of childbearing potential who has a positive pregnancy test (Urine-hCG or Serum hCG) at a screening visit or does not agree to use at least one of medically acceptable, effective contraceptive methods*. However, females who reached menopause at least one year ago or turned out infertile due to an operation should be excluded.
- Effective contraceptive methods: intrauterine devices (e.g., IUD, mirena), dual barrier methods (diaphragm or condom/femidom + spermicide), and parenteral contraceptives. Continuing only sexual abstinence is not viewed as an acceptable method.
- A woman of childbearing potential who neither practices adequate contraception nor agrees to continue its use for at least 18 weeks after the last dose of the study drug.
- Those decided by the investigator to be not eligible for this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
If subjects voluntarily consent to participation in the study, those who are finally determined to be eligible for the study after whether all of the inclusion criteria and none of the exclusion criteria are met is checked will receive the study drug. Efficacy and safety will be evaluated at baseline, baseline, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, 38 weeks, 46 weeks, and 54 weeks.
Read the detailed description
This study, which is designed as a multicenter, open-label, single-arm, phase 3b clinical trial, is intended to evaluate the efficacy and safety of vedolizumab in biologic-naïve Korean patients with moderate-to-severe bowel disease.
The study is conducted with a single arm, and the subjects to be recruited consist of 30 patients with Crohn's disease and 30 patients with ulcerative colitis (considering dropout rate of 20%).
The total period after the subject enrollment is 54 weeks, and a total of 10 visits are made with screening, baseline, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, 38 weeks, 46 weeks, and 54 weeks.
- Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks.The maximum dosing period is 54 weeks.
- Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks.The maximum dosing period is 54 weeks.
- Conditions
- Crohn's Disease and Ulcerative Colitis
- Being tested
- Vedolizumab
- Keywords
- inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
- Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks.
- Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab | Experimental | * Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks.
* Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase
Clinical remission is defined as Mayo score ≤ 2 points and individual score ≤ 1 point for Ulcerative colitis and CDAI(Crohn's Disease Activity Index) < 150 for Crohn's Disease.
Measured: 14 weeks
Clinical remission rate (%) at 54 weeks in maintenance phase
Clinical remission is defined as Mayo score ≤ 2 points and individual score ≤ 1 point for Ulcerative colitis and CDAI(Crohn's Disease Activity Index) < 150 for Crohn's Disease.
Measured: 54 weeks
Secondary outcomes (12)
Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks
Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks
Measured: 6 weeks, 54 weeks
Mucosal healing rate at 14 weeks and 54 weeks
Mucosal healing is defined as Mayo endoscopic subscore ≤ 1 for UC and as no visible ulcer for Crohn's Disease.
Measured: 14 weeks, 54 weeks
Steroid free remission rate at 54 weeks
Steroid free remission rate at 54 weeks
Measured: 54 weeks
Transmural healing rate at 14 weeks and 54 weeks for Crohn's Disease
Transmural healing is defined as normal cross-sectional imaging and mucosal healing.
Measured: 14 weeks, 54 weeks
Correlation of CRP(C-reactive protein) level with clinical remission at 54 weeks.
The logistic regression will analyze CRP level to see the correlation with clinical remission.
Measured: 54 weeks
Correlation of fecal calprotectin level with clinical remission at 54 weeks
The logistic regression will analyze fecal calprotectin level to see the correlation with clinical remission.
Measured: 54 weeks
Correlation of endoscopic severity with clinical remission at 54 weeks
The logistic regression will analyze endoscopic severity to see the correlation with clinical remission.
Measured: 54 weeks
Correlation of radiologic severity with clinical remission at 54 weeks
The quality of life(QoL) will be assessed by IBDQ(Inflammatory Bowel The logistic regression will analyze radiologic severity to see the correlation with clinical remission.
Measured: 54 weeks
Correlation of CDAI(Crohn's Disease Activity Index) score with clinical remission at 54 weeks
The logistic regression will analyze CDAI score to see the correlation with clinical remission.
Measured: 54 weeks
Correlation of Mayo score with clinical remission at 54 weeks
The logistic regression will analyze Mayo score to see the correlation with clinical remission.
Measured: 54 weeks
Changes in fecal microbiota after vedolizumab treatment: Microbiota change will be compared with baseline status using α diversity and β diversity.
Changes in fecal microbiota at 14 weeks and 54 weeks after treatment versus baseline are evaluated by α-diversity and β-diversity.
Measured: Baseline, 14 weeks, 54 weeks
QoL(Quality of Life): IBDQ(Inflammatory Bowel Disease Questionnaire)
The quality of life(QoL) will be assessed by IBDQ(Inflammatory Bowel Disease Questionnaire) survey at week 0, week 14 and week 54. A paired data analysis will be conducted at week 14 and week 54 compared to week 0 (before treatment). It will be evaluated in Crohn's Disease and Ulcerative colitis, separately.
Measured: Baseline, 14 weeks, 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease and Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae hee Cheon, MD, PhD, Principal investigator, Severance Hospital of Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919252
- Sponsor's protocol ID
- 4-2020-1365
- Acronym
- VEDOKO-IIT
- Status last verified
- Jun 2021
- First submitted
- 6 Apr 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04919252
- Acronym / sponsor ID
- VEDOKO-IIT / 4-2020-1365
- Conditions
- Crohn's Disease and Ulcerative Colitis
- Keywords
- inflammatory bowel disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 9 Jun 2021 (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.
If subjects voluntarily consent to participation in the study, those who are finally determined to be eligible for the study after whether all of the inclusion criteria and none of the exclusion criteria are met is checked will receive the study drug. Efficacy and safety will be evaluated at baseline, baseline, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, 38 weeks, 46 weeks, and 54 weeks.
Detailed description
This study, which is designed as a multicenter, open-label, single-arm, phase 3b clinical trial, is intended to evaluate the efficacy and safety of vedolizumab in biologic-naïve Korean patients with moderate-to-severe bowel disease.
The study is conducted with a single arm, and the subjects to be recruited consist of 30 patients with Crohn's disease and 30 patients with ulcerative colitis (considering dropout rate of 20%).
The total period after the subject enrollment is 54 weeks, and a total of 10 visits are made with screening, baseline, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, 38 weeks, 46 weeks, and 54 weeks.
- Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks.The maximum dosing period is 54 weeks.
- Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks.The maximum dosing period is 54 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab | Experimental | Drug: Vedolizumab* Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. * Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥ 19 years to ≤ 70 years
- Patients with moderate-to-severe active Crohn's disease or ulcerative colitis who are unresponsive to, become unresponsive to, or have no tolerability to universal treatment (with corticosteroids, immunomodulators, etc.)
Key exclusion criteria (14 listed)
- A history of total colectomy
- Acute severe UC(Ulcerative Colitis)
- A potential for a bowel resection surgery within 3 months
- Pregnancy and breastfeeding
- Prior use of any biologics including anti-TNFs, ustekinumab, and tofacitinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab* Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. * Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. | Drug | Vedolizumab |
Primary outcome
Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase
Time frame: 14 weeks
Clinical remission is defined as Mayo score ≤ 2 points and individual score ≤ 1 point for Ulcerative colitis and CDAI(Crohn's Disease Activity Index) < 150 for Crohn's Disease.
Clinical remission rate (%) at 54 weeks in maintenance phase
Time frame: 54 weeks
Clinical remission is defined as Mayo score ≤ 2 points and individual score ≤ 1 point for Ulcerative colitis and CDAI(Crohn's Disease Activity Index) < 150 for Crohn's Disease.
12 secondary outcomes
Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks
Time frame: 6 weeks, 54 weeks
Mucosal healing rate at 14 weeks and 54 weeks
Time frame: 14 weeks, 54 weeks
Steroid free remission rate at 54 weeks
Time frame: 54 weeks
Transmural healing rate at 14 weeks and 54 weeks for Crohn's Disease
Time frame: 14 weeks, 54 weeks
Correlation of CRP(C-reactive protein) level with clinical remission at 54 weeks.
Time frame: 54 weeks
Correlation of fecal calprotectin level with clinical remission at 54 weeks
Time frame: 54 weeks
Correlation of endoscopic severity with clinical remission at 54 weeks
Time frame: 54 weeks
Correlation of radiologic severity with clinical remission at 54 weeks
Time frame: 54 weeks
Correlation of CDAI(Crohn's Disease Activity Index) score with clinical remission at 54 weeks
Time frame: 54 weeks
Correlation of Mayo score with clinical remission at 54 weeks
Time frame: 54 weeks
Changes in fecal microbiota after vedolizumab treatment: Microbiota change will be compared with baseline status using α diversity and β diversity.
Time frame: Baseline, 14 weeks, 54 weeks
QoL(Quality of Life): IBDQ(Inflammatory Bowel Disease Questionnaire)
Time frame: Baseline, 14 weeks, 54 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jae hee Cheon, MD, PhD principal investigator
Severance Hospital of Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vedolizumab in people with Crohn's Disease and Ulcerative Colitis, run by Yonsei University 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae hee Cheon, MD, PhD (82-2-2228-1990, geniushee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase (time frame: 14 weeks). The study lists 2 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 9 Jun 2021.