A Phase 3 interventional study of Vedolizumab IV and Vedolizumab SC in Ulcerative Colitis and Crohn's Disease, sponsored by Takeda. Recruiting at 54 sites in 16 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Takeda · Phase 3, Interventional, and Treatment
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.
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab.
The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as:
At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period:
This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).
1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.
This study's planned enrollment of 70 is close to the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:
Exclusion Criteria:
Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Drug: Vedolizumab 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.
Drug: Vedolizumab 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.
Drug: Vedolizumab IV
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.
Drug: Vedolizumab SC
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.
Drug: Vedolizumab SC
Vedolizumab IV injection.
Also known as: ENTYVIO, KYNTELES, MLN0002
Vedolizumab SC injection.
Also known as: MLN0002SC
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
Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34
Time frame: Multiple time points prior to Week 34; pre-dose at Week 34
Percentage of Participants with Positive Antivedolizumab Antibody (AVA)
Time frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Percentage of Participants with Positive Neutralizing AVA
Time frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
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