Back to resultsEfficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease (VEDOKO-IIT)
Primary Purpose
Crohn's Disease and Ulcerative Colitis
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vedolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease and Ulcerative Colitis focused on measuring inflammatory bowel disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vedolizumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
Steroid free remission rate at 54 weeks
Steroid free remission rate at 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.
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.
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.
Correlation of endoscopic severity with clinical remission at 54 weeks
The logistic regression will analyze endoscopic severity to see the correlation with clinical remission.
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.
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.
Correlation of Mayo score with clinical remission at 54 weeks
The logistic regression will analyze Mayo score to see the correlation with clinical remission.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04919252
Brief Title
Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease
Acronym
VEDOKO-IIT
Official Title
Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease and Ulcerative Colitis
Keywords
inflammatory bowel disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vedolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase
Description
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.
Time Frame
14 weeks
Title
Clinical remission rate (%) at 54 weeks in maintenance phase
Description
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.
Time Frame
54 weeks
Secondary Outcome Measure Information:
Title
Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks
Description
Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks
Time Frame
6 weeks, 54 weeks
Title
Mucosal healing rate at 14 weeks and 54 weeks
Description
Mucosal healing is defined as Mayo endoscopic subscore ≤ 1 for UC and as no visible ulcer for Crohn's Disease.
Time Frame
14 weeks, 54 weeks
Title
Steroid free remission rate at 54 weeks
Description
Steroid free remission rate at 54 weeks
Time Frame
54 weeks
Title
Transmural healing rate at 14 weeks and 54 weeks for Crohn's Disease
Description
Transmural healing is defined as normal cross-sectional imaging and mucosal healing.
Time Frame
14 weeks, 54 weeks
Title
Correlation of CRP(C-reactive protein) level with clinical remission at 54 weeks.
Description
The logistic regression will analyze CRP level to see the correlation with clinical remission.
Time Frame
54 weeks
Title
Correlation of fecal calprotectin level with clinical remission at 54 weeks
Description
The logistic regression will analyze fecal calprotectin level to see the correlation with clinical remission.
Time Frame
54 weeks
Title
Correlation of endoscopic severity with clinical remission at 54 weeks
Description
The logistic regression will analyze endoscopic severity to see the correlation with clinical remission.
Time Frame
54 weeks
Title
Correlation of radiologic severity with clinical remission at 54 weeks
Description
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.
Time Frame
54 weeks
Title
Correlation of CDAI(Crohn's Disease Activity Index) score with clinical remission at 54 weeks
Description
The logistic regression will analyze CDAI score to see the correlation with clinical remission.
Time Frame
54 weeks
Title
Correlation of Mayo score with clinical remission at 54 weeks
Description
The logistic regression will analyze Mayo score to see the correlation with clinical remission.
Time Frame
54 weeks
Title
Changes in fecal microbiota after vedolizumab treatment: Microbiota change will be compared with baseline status using α diversity and β diversity.
Description
Changes in fecal microbiota at 14 weeks and 54 weeks after treatment versus baseline are evaluated by α-diversity and β-diversity.
Time Frame
Baseline, 14 weeks, 54 weeks
Title
QoL(Quality of Life): IBDQ(Inflammatory Bowel Disease Questionnaire)
Description
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.
Time Frame
Baseline, 14 weeks, 54 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae hee Cheon, MD, PhD
Phone
82-2-2228-1990
Email
geniushee@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae hee Cheon, MD, PhD
Organizational Affiliation
Severance Hospital of Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease
We'll reach out to this number within 24 hrs