Long-term safety of vedolizumab under the skin in children with bowel inflammation

AI summary

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

The registry criteria, word for word

Check if you might fit

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?YesNo

What the trial wants to find out

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.

The 3 groups in the trial

• Treatment Cohort: Vedolizumab 108 mg PFS+AITreatment being tested

  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.

  Treatment: Vedolizumab SC

• Treatment Cohort: Vedolizumab 108 mg PFS+NSDTreatment being tested

  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.

  Treatment: Vedolizumab SC

• Observational Cohort: Early Terminated Participants From Parent StudyOther group

  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.