Long-term safety of vedolizumab under the skin in children with bowel inflammation
Checks long-term side effects of vedolizumab under the skin in children with colitis or Crohn's.
Plain-language title generated from the registry record
Registry title: A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Key facts
- Where
- Messina, Milan, Pescara, and Rome, ItalySee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with ulcerative colitis or Crohn's disease who took part in the earlier vedolizumab SC study (VedolizumabSC-3003). Those who responded well keep getting vedolizumab SC; the others are followed without treatment.
- Age
- 2 to 17 years
- Sex
- All sexes
- Disease stage
- Ulcerative colitis or Crohn's disease. Treatment group: completed Week 34 of the earlier study and had a clinical response at Week 34.
- Earlier treatment
- Must have received vedolizumab in study VedolizumabSC-3003. Treatment group: no corticosteroids for at least the last 4 weeks (Week 30 to Week 34) of that study.
Main reasons for not taking part
- Allergy or hypersensitivity to vedolizumab or any of its ingredients (treatment group)
- Needs major surgery for UC or CD now, or is expected to need it during the study (treatment group)
- Did not respond well or took corticosteroids in the last 4 weeks of the earlier study: cannot join the treatment group, only the follow-up group
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT06405087, who can take part
Where in Italy
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyNot yet recruiting
- ASST Fatebenefratelli SaccoMilan, ItalyNot yet recruiting
- Azienda Sanitaria Locale di PescaraPescara, ItalyNot yet recruiting
- Ospedale Pediatrico Bambino GesùRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Takeda
- Trial code
- NCT06405087EU 2023-508804-39-00
- Record updated
- 9 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
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.
Inclusion: 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: 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; Has hypersensitivity or allergies to vedolizumab or any of its excipients.