A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Conditions

• Crohn's Disease
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab IV — DRUG
  Vedolizumab IV injection.
• Vedolizumab SC — DRUG
  Vedolizumab SC injection.

Study Details

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.

Key Dates

Start date

Jan 22, 2025

Status verified

May 2026

Primary completion

Nov 15, 2027

Completion

Nov 15, 2027

Study Design

Enrollment

70 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV
  Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
• Experimental: Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV
  Participants weighing \>15 to \<30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
• Experimental: Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV
  Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
• Experimental: Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W
  Participants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period.
• Experimental: Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W
  Participants with clinical response at Week 14 weighing ≥10 to \<30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period.

Primary Outcome Measure

Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34 [ Time Frame: Predose at Week 34 ]

Central Contacts

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

Locations (14)

Find similar trials in Phoenix, AZ

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