Long-term vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The University of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting
• UMHAT Sv. Georgi, EAD
  Plovdiv, Bulgaria Recruiting
• Juntendo University Hospital
  Bunkyo-ku, Tokyo, Japan Recruiting
• Korczowski Bartosz, Gabinet Lekarski
  Rzeszów, Poland Recruiting
• WIP Warsaw IBD Point Profesor Kierkus
  Warsaw, Poland Recruiting
• Instytut Pomnik - Centrum Zdrowia Dziecka
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment of Ulcerative Colitis and Crohn's Disease with Vedolizumab

  This study is testing if a new medication called Vedolizumab can help adults with Ulcerative Colitis or Crohn's Disease feel better and stay symptom-free over a year.

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• Vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease

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  Recruiting at 26 sites Phase 3 Takeda · Phoenix, Arizona and 53 other locations · NCT06100289

• Vedolizumab treatment for children with ulcerative colitis or Crohn's disease

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  Recruiting at 44 sites Phase 3 Takeda · Mobile, Alabama and 97 other locations · NCT05442567

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  This study is looking at how well the medication vedolizumab works for adults in South Korea with moderate to severe ulcerative colitis or Crohn's disease who haven't had success with other treatments.

  Recruiting Takeda · Goyang-si, Gyeonggi-do · NCT05428345

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

• Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease

  This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07619547

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.