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Study details
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A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease

Takeda
NCT IDNCT06581328ClinicalTrials.gov data as of Apr 2026
Phase

Phase 4

Target enrollment

400

Study length

about 3.2 years

Ages

18–80

Locations

98 sites in AL, AR, AZ +29

About this study

This trial is testing how many adults with ulcerative colitis (UC) or Crohn's disease (CD) will have their symptoms disappear after 3.5 months of treatment with Vedolizumab, a medication given as an infusion and then by injection for the rest of it period. Participants will visit the clinic several times during it.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive Vedolizumab IV
  • 2.Take Vedolizumab SC
PhasePhase 4
DrugVedolizumab IV
Routeinjection
Primary goalPercentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low15%
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: Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14, Percentage of UC Participants With PRO-2 Remission at Week 14

Secondary: Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, and 52, Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52, Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52

Body systems

Gastroenterology