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Monoclonal Antibodies

Vedolizumab for Ulcerative Colitis

Phase 3

Waitlist Available

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.

Must not have

Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.

Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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My ulcerative colitis is active and not responding to current treatments.

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My ulcerative colitis extends beyond the rectum.

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I weigh at least 10 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a serious infection like pneumonia or COVID-19 in the last 30 days.

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I haven't taken any experimental or approved biologic drugs recently.

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I have had surgery to remove all or part of my colon, or I have a stoma or known narrow section in my intestine.

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I do not have active brain disorders like PML, MS, or a brain tumor.

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I have tested positive for tuberculosis recently.

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I have been diagnosed with indeterminate colitis.

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I have been treated with specific drugs targeting cell adhesion before.

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I have signs of a genetic form of very early onset IBD.

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I have had skin cancer or early-stage cervical cancer but no other cancers.

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I need or might need surgery for my bladder cancer during the study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score

Secondary study objectives

Change from Baseline in Linear Growth Z-score

Change from Baseline in Weight

Change in Tanner Stage at Week 54 Compared with Baseline

+14 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT02559713

Colitis ulcerative

Gastrointestinal motility disorder

Viral infection

Crohn's disease

Paronychia

100%

80%

60%

40%

20%

Study treatment Arm

Vedolizumab 300 mg

Awards & Highlights

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.

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

~10220

0 / 13Eligibility criteria met