Vedolizumab for Crohn's Disease

Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Takeda

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

Eligibility Criteria

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.

Inclusion Criteria

I weigh at least 10 kg.

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

Exclusion Criteria

I have been diagnosed with indeterminate colitis.

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

I have had significant surgery on my intestines.

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

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

I have chronic hepatitis C.

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

I need or might need surgery for Crohn's disease during the study.

Treatment Details

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.

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.

Vedolizumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Entyvio for: