RightFit
RecruitingPhase 3

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

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The overall time to participate in this study is up to 2 years from the first dose in the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at medical problems from long-term use of vedolizumab shots under the skin in children and teens with ulcerative colitis or Crohn’s disease, which cause bowel swelling. It also looks at hospital visits for bowel swelling and quality of life. Children and teens from an earlier study may keep getting the drug or be followed without it for up to 2 years after their last dose.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • To keep getting the drug: Finished week 34 of the earlier study, VedolizumabSC-3003 (NCT06100289).
  • To keep getting the drug: Symptoms improved enough by week 34 to meet the study’s scoring rules.
  • To keep getting the drug: Had no corticosteroids (steroid medicines) during at least the last 4 weeks of the earlier study.
  • To be followed without the drug: Got at least 1 dose in the earlier study and either left early or finished the week 34 visit but did not qualify to keep getting treatment.

Who can't join

  • Cannot keep getting the drug if allergic to vedolizumab or any of its ingredients.
  • Cannot keep getting the drug if major surgery for ulcerative colitis or Crohn’s disease is needed now or expected during the study, such as surgery to remove part of the bowel.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (13)

AZ

CA

IL

MI

NJ

NY

OH

OK

PA

  • Penn State Health Milton South Hershey Medical Center · Hershey, PA 17033Site Contact · Study contact · sqg5835@psu.eduStefany Garrity · Principal investigatorMore trials in Hershey

SC

WA