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Monoclonal Antibodies

Vedolizumab for Crohn's Disease

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

The participants weigh ≥10 kg at the time of screening and enrollment into the study.

The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).

Must not have

Participants with a current diagnosis of indeterminate colitis.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will help researchers learn more about the safety and effectiveness of vedolizumab in children and teenagers with Crohn's disease.

Who is the study for?

This trial is for children and teenagers with moderate to severe Crohn's disease who haven't responded well to standard treatments like corticosteroids, immunomodulators, or TNF-α antagonists. They should weigh at least 10 kg and have been diagnosed with CD at least a month prior. Participants must be up-to-date on vaccinations but can't join if they've had certain surgeries, other conditions like TB or hepatitis B/C, recent infections including COVID-19, or any history of malignancy.

What is being tested?

The study tests Vedolizumab IV in young patients with Crohn's Disease. Initially, all participants receive three infusions over six weeks. Those responding will continue receiving either a high dose or low dose every eight weeks. The goal is to see if the treatment leads to remission—meaning their symptoms improve significantly or disappear entirely.

What are the potential side effects?

Vedolizumab may cause side effects such as risk of infection due to weakened immune response, allergic reactions during infusion (like itching or rash), headache, joint pain, nausea and fever. Some might experience more serious issues like liver problems or progressive multifocal leukoencephalopathy (PML), a rare brain infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 10 kg.

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My Crohn's disease is active and not responding to current treatments.

Exclusion Criteria

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

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I have been diagnosed with indeterminate colitis.

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I have not had a serious infection like pneumonia or COVID-19 in the last 30 days.

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I have had significant surgery on my intestines.

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

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I have a condition that weakens my immune system, such as HIV.

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I have chronic hepatitis C.

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I do not have active brain disorders or a history of serious neurological conditions.

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I need or might need surgery for Crohn's disease 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 Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10

Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score

Secondary study objectives

Change from Baseline in Linear Growth Z-score

Change from Baseline in Tanner Stages at Week 54

Change from Baseline in Weight

+12 more

Side effects data

From 2020 Phase 4 trial • 278 Patients • NCT03029143

Colitis ulcerative

Headache

C-reactive protein increased

100%

80%

60%

40%

20%

Study treatment Arm

Lead-in Failure Follow-up Period

RTP: VDZ Dose Optimization: Regimen A

RTP: Standard Treatment Arm

RTP: VDZ Dose Optimization: Regimen B

Lead-in Period

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Maintenance Period: ≥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 II: Maintenance Period: ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention

Vedolizumab 300 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 high dose arm group will receive vedolizumab 300 mg.

Group III: Maintenance Period: >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: >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: 10 to 15 kg Vedolizumab 150 mgExperimental Treatment1 Intervention

Vedolizumab 150 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 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: 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: ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention

Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.

Group VIII: Induction Period: >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention

Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of \>15 to \<30 kg will be included in this arm group.

Group IX: Induction Period: 10 to 15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention

Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab IV

2014

Completed Phase 4

~700

0 / 10Eligibility criteria met