A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Conditions

• Crohn's Disease (CD)

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab IV — DRUG
  Vedolizumab IV

Study Details

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.

Key Dates

Start date

Feb 10, 2022

Status verified

Apr 2026

Primary completion

Sep 13, 2027

Completion

Sep 13, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Induction Period: 10 to 15 kg, Vedolizumab 150 mg
  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.
• Experimental: Induction Period: >15 to <30 kg, Vedolizumab 200 mg
  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.
• Experimental: Induction Period: ≥30 kg, Vedolizumab 300 mg
  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.
• Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
  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.
• Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 100 mg
  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.
• Experimental: Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg
  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.
• Experimental: Maintenance Period: >15 to <30 kg Vedolizumab 100 mg
  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.
• Experimental: Maintenance Period: ≥30 kg, Vedolizumab 300 mg
  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.
• Experimental: Maintenance Period: ≥30 kg: Vedolizumab 150 mg
  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.

Primary Outcome Measure

Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10 [ Time Frame: Week 54 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (22)

Find similar trials in Phoenix, AZ

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