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Monoclonal Antibodies

Vedolizumab for Ulcerative Colitis and 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every 24 weeks in this study (up to approximately 5 years)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is an extension of two previous studies and is looking at the long-term safety of vedolizumab in children with ulcerative colitis or Crohn's disease who participated in the earlier

Who is the study for?

This trial is for children with Ulcerative Colitis or Crohn's Disease who completed previous studies MLN0002-3024 or MLN0002-3025 and responded well without steroids. Participants must agree to use effective contraception if they are sexually active.

What is being tested?

The study tests the long-term safety of Vedolizumab, a medication given through IV, in children. It extends two prior studies and continues to monitor those who previously received Vedolizumab.

What are the potential side effects?

While not explicitly listed here, common side effects of Vedolizumab may include headache, joint pain, nausea, fever, infections, and potential infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 24 weeks in this study (up to approximately 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every 24 weeks in this study (up to approximately 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 24 weeks in this study (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Observational Cohort: Number of Participants With Prespecified Safety Events

Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)

Secondary study objectives

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

7Treatment groups

Experimental Treatment

Group I: Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group II: Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group III: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group IV: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group V: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group VI: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group VII: Observational Cohort: Early Terminated Participants From Parent StudiesExperimental Treatment1 Intervention

Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab

FDA approved

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