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

Takeda
NCT IDNCT05442567ClinicalTrials.gov data as of Apr 2026
Check if I qualifyBack to resultsClinicalTrials.gov
Phase

Phase 3

Target enrollment

240

Study length

about 8.3 years

Ages

2+

Locations

14 sites in AZ, CA, GA +10

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.No Intervention
  • 2.Receive Vedolizumab IV
PhasePhase 3
DrugVedolizumab IV
Routeinjection
Primary goalTreatment Cohort: Number of Participants With at Least One Adverse Event (AE)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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

Check if I qualifyView on ClinicalTrials.gov