Long-term vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
This extension tests whether continuing subcutaneous vedolizumab is safe and helps children and teenagers with moderate to severe ulcerative colitis or Crohn's disease stay well.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | vedolizumab |
| Locations | 1 site (Bunkyo-ku, Tokyo) |
| Trial ID | NCT06405087 on ClinicalTrials.gov |
What this trial studies
This is a long-term extension for pediatric participants who received vedolizumab SC in the parent VedolizumabSC-3003 study and focuses on safety, timing of hospital visits for flares, and quality of life over up to two years. About 70 participants will be enrolled into a treatment cohort or an observational cohort depending on response in the parent study. Responders who join the treatment cohort will continue the same dose and be randomized 1:1 to receive vedolizumab 108 mg via prefilled syringe with an autoinjector pen versus a syringe with a needle safety device, while nonresponders or those who recently used corticosteroids will be followed without additional study drug. Regular clinic visits and an 18-week post-treatment safety follow-up (for treatment cohort) will collect adverse events and efficacy-related measures.
Who should consider this trial
Good fit: Ideal candidates are pediatric participants who completed Week 34 of the parent VedolizumabSC-3003 study, achieved clinical response, and were corticosteroid-free for at least the last four weeks.
Not a fit: Children who did not respond to vedolizumab in the parent trial or who received corticosteroids in the last four weeks of that trial are unlikely to receive benefit from continued vedolizumab in this extension and will be followed observationally.
Why it matters
Potential benefit: If successful, the extension could show that long-term self‑administered vedolizumab is safe in children and teens and may help maintain remission, reduce hospital visits, and improve quality of life.
How similar studies have performed: Vedolizumab has shown safety and efficacy in adult and pediatric trials (including the parent VedolizumabSC-3003), but long-term pediatric data for the subcutaneous formulation are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bunkyo-ku, Tokyo
- Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.