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Monoclonal Antibodies
Vedolizumab for Ulcerative Colitis
Phase 3
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).
Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Awards & highlights
Study Summary
This trial will help researchers learn more about how vedolizumab works in children and teenagers with ulcerative colitis.
Who is the study for?
This trial is for children and teenagers weighing at least 10 kg with moderate to severe ulcerative colitis diagnosed over a month ago. They must have tried treatments like corticosteroids or TNF-α antagonists without success, or cannot tolerate them. Participants should not have had certain surgeries, live vaccines recently, other biologic treatments too close to the study start, active infections including TB or hepatitis B/C, or any history of neurological disorders.Check my eligibility
What is being tested?
The trial tests Vedolizumab's effectiveness in achieving remission from ulcerative colitis symptoms in young patients. Remission is when symptoms improve greatly or disappear and an endoscopy shows little to no disease signs. Initially, participants get three infusions over six weeks; responders continue with one of three doses every eight weeks.See study design
What are the potential side effects?
Vedolizumab may cause side effects such as infusion-related reactions (like pain or discomfort at the injection site), risk of infection due to weakened immune response, potential liver problems indicated by yellowing skin/eyes (jaundice), fatigue, headache, joint pains and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ulcerative colitis is active and not responding to current treatments.
Select...
My ulcerative colitis extends beyond the rectum.
Select...
I weigh at least 10 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score
Secondary outcome measures
Change from Baseline in Linear Growth Z-score
Change from Baseline in Weight
Change in Tanner Stage at Week 54 Compared with Baseline
+17 moreSide effects data
From 2019 Phase 4 trial • 11 Patients • NCT025597139%
Crohn's disease
9%
Gastrointestinal motility disorder
9%
Paronychia
9%
Viral infection
9%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vedolizumab 300 mg
Trial Design
9Treatment groups
Experimental Treatment
Group I: Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Group II: Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Group III: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Group IV: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Group V: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Group VI: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Group VII: Induction Period: Participants ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.
Group VIII: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg are included in this arm.
Group IX: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vedolizumab
2009
Completed Phase 4
~10330
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,824 Total Patients Enrolled
24 Trials studying Ulcerative Colitis
9,254 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a serious infection like pneumonia or COVID-19 in the last 30 days.I haven't taken any experimental or approved biologic drugs recently.I have had surgery to remove all or part of my colon, or I have a stoma or known narrow section in my intestine.My ulcerative colitis is active and not responding to current treatments.My ulcerative colitis extends beyond the rectum.I do not have active brain disorders like PML, MS, or a brain tumor.I have tested positive for tuberculosis recently.I have been diagnosed with indeterminate colitis.I have been treated with specific drugs targeting cell adhesion before.I have signs of a genetic form of very early onset IBD.My previous treatments for my condition, including steroids or immunomodulators, have not worked or caused side effects.I have been tested for hepatitis B, and either have it or am immune.I have chronic hepatitis C or had it but now show no signs of the virus.I was diagnosed with UC over a month ago and it's moderately to severely active.I have not had any live vaccines in the last 30 days.I have had severe colitis for over 8 years or left-sided colitis for over 12 years and a recent colonoscopy showed no cancer.I have had skin cancer or early-stage cervical cancer but no other cancers.I need or might need surgery for my bladder cancer during the study.I weigh at least 10 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg
- Group 2: Induction Period: Participants ≥30 kg, Vedolizumab 300 mg
- Group 3: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
- Group 4: Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg
- Group 5: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg
- Group 6: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg
- Group 7: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
- Group 8: Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg
- Group 9: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being sought for this particular clinical trial?
"According to the age parameters set out in this trial's inclusion criteria, the minimum age for enrollment is 2 years old and the maximum age is 17."
Answered by AI
Vedolizumab has received FDA approval, correct?
"Vedolizumab is a Phase 3 medication, meaning that while there is some data supporting efficacy, multiple rounds of testing have verified its safety."
Answered by AI
What is the total patient enrollment for this research?
"The sponsor, Takeda, needs to enroll 120 eligible patients from different locations in order to conduct the study. Some of these places include Goryeb Children's Hospital in Morristown, New jersey and Boston Children's Hospital in Boston, Massachusetts."
Answered by AI
To your knowledge, does a similar study exist?
"Vedolizumab has undergone 23 clinical trials in 42 countries and 312 cities since 2015. The first study, sponsored by Takeda, completed Phase 4 drug approval with 260 patients. In the six years since then, an additional 38 studies have been conducted."
Answered by AI
Could you please specify how many research facilities in North America are conducting this clinical trial?
"There are 26 medical centres where this clinical trial is enrolling patients. Some of these locations include Morristown, Boston and Lake Success. To reduce the amount you would need to travel, it is best to select a centre near you."
Answered by AI
Could I be a candidate for this clinical research?
"This study is looking for children and adolescents between the ages of 2 and 17 who have colitis or ulcerative colitis. Patients must meet the following criteria: moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC), weighs ≥10 kg at the time of screening and enrollment into the study, has moderately to severely active UC diagnosed at least 1 month before screening, defined by a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with"
Answered by AI
Are there any patients enrolled in this research project presently?
"Indeed, the clinical trial is currently looking for 120 patients at 26 sites, as seen on clinicaltrials.gov. The first posting was on 10/19/2021 with the latest edit happening 8/25/2022."
Answered by AI
Could you please share if there have been any other Vedolizumab research studies?
"Vedolizumab was first studied in 2015 at AZ Delta Roeselare. To date there have been 38 completed trials and 23 live trials. Many of the ongoing studies are based out of Morristown, New jersey."
Answered by AI
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