Recruiting
Phase 3

Vedolizumab SC

Sponsor:

Takeda

Code:

NCT06405087

Conditions

Ulcerative Colitis

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Vedolizumab SC

No Intervention

Study Details

Brief summary:

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.

In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.

During the study, participants will visit their study clinic several times.

Conditions

Ulcerative Colitis

Crohn's Disease

Study ID

NCT06405087

Start date

Oct 27, 2025

Status verified date

Jun, 2026

Completion date

Aug 12, 2030

Anticipated

Primary completion date

Aug 12, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of >=2 points and >= 25 percentage (%) from baseline (from VedolizumabSC-3003 \[NCT06100289\]), including a >=1-point decrease in the Mayo stool frequency subscore and a >=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) <=30 with a reduction in the PCDAI of >=15 points from baseline (from VedolizumabSC-3003 \[NCT06100289\]).

Inclusion Criteria for Observational Cohort

1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.

Exclusion Criteria for Treatment Cohort

1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Cohort: Vedolizumab 108 mg PFS+AI

Vedolizumab 108 mg, PFS+AI, subcutaneously, once every two weeks (Q2W) to the participants weighing greater than or equal to (>=) 30 kg and once every four weeks (Q4W) to the participants weighing >=10 to less than (<) 30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.

experimental: Treatment Cohort: Vedolizumab 108 mg PFS+NSD

Vedolizumab 108 mg, PFS+NSD, subcutaneously, Q2W to the participants weighing >=30 kg and Q4W to the participants weighing >=10 to <30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.

other: Observational Cohort: Early Terminated Participants From Parent Study

Participants who receive any dose of vedolizumab SC during the parent study VedolizumabSC-3003 (NCT06100289) and are not eligible for the treatment cohort of this extension study (that is, participants who early terminated from parent study VedolizumabSC-3003 \[NCT06100289\] or did not achieve clinical response in the parent study or who received corticosteroids in the last 4 weeks of the parent study) will only be observed in the observational cohort of this study and will not receive any dose of the vedolizumab SC in this cohort.

Interventions

Vedolizumab SC

Vedolizumab subcutaneous injection.

No Intervention

As this is an observational cohort, no intervention will be administered.

Primary outcome measure

  • Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138) ]
  • Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs) [ Time Frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138) ]
  • Observational Cohort: Number of Participants With Prespecified Safety Events [ Time Frame: Up to Week 86 ]

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327medinfoUS@takeda.com

Locations

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Contact

Sirish-Palle@ouhsc.edu

Principal Investigator:

Sirish Palle

More Information

Sponsor

Takeda

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Drug Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Takeda on 2026-06-22.