A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT IDNCT05442567ClinicalTrials.gov data as of Apr 2026

Check if I qualify Back to results ClinicalTrials.gov

Phase

Phase 3

Target enrollment

240

Study length

about 8.3 years

Ages

Locations

14 sites in AZ, CA, GA +10

What this study is about

Researchers are testing the long-term safety of vedolizumab, a drug given by infusion, in children with ulcerative colitis (UC) or Crohn's disease (CD). Participants must have previously participated in another trial. It will last for 3013 days.

Simplified from trial records by PatientMatch.

What you may be asked to do

1.No Intervention
2.Receive Vedolizumab IV

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel

In-person visits

Requires travel to a study site

Physical Intervention

Injection / IVInjection / IV

How treatment is administered

Treatment Assignment

All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

vedolizumab

Drug routes

injection, intravenous, infusion

Endpoints

Primary: Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)

Secondary: Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks, Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks, Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks, Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks, Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks, Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks, Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

Body systems

Gastroenterology

Screen for this study View on ClinicalTrials.gov