A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT06405087 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: VedolizumabSC-30042023-508804-39-00jRCT2031250519
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening.

  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)

  AESI is defined as infections, including opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions.

  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

  Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.

  Up to Week 86

Secondary Outcomes (2)

• Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events

  Up to Week 120

• Treatment Cohort: Change from Baseline in IMPACT-III Scores

  Baseline, every 24 weeks in this study (up to Week 120)

Study Arms (3)

Treatment Cohort: Vedolizumab 108 mg PFS+AI

EXPERIMENTAL

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.

Drug: Vedolizumab SC

Treatment Cohort: Vedolizumab 108 mg PFS+NSD

EXPERIMENTAL

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.

Drug: Vedolizumab SC

Observational Cohort: Early Terminated Participants From Parent Study

OTHER

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.

Other: No Intervention

Interventions

Vedolizumab SC DRUG

Vedolizumab subcutaneous injection.

Also known as: MLN0002

Treatment Cohort: Vedolizumab 108 mg PFS+AI; Treatment Cohort: Vedolizumab 108 mg PFS+NSD

No Intervention OTHER

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

Observational Cohort: Early Terminated Participants From Parent Study

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.

You may not qualify if:

• Has hypersensitivity or allergies to vedolizumab or any of its excipients.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: October 27, 2025
• Primary Completion (Estimated): January 26, 2032
• Study Completion (Estimated): January 26, 2032
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)