Vedolizumab for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+138 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

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 ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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

My ulcerative colitis extends beyond the rectum.

My previous treatments for my condition, including steroids or immunomodulators, have not worked or caused side effects.

See 4 more

Exclusion 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.

See 12 more

Treatment Details

Interventions

Vedolizumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

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

🇪🇺 Approved in European Union as Entyvio for: