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A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Name: A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease — clinical trial record (NCT06045754)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 4

SponsorTakeda

Started2024-04-18

View on ClinicalTrials.gov ↗

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.

Amendment history 2 changes detected by DataLookout

2026-09-01

Enrollment reduced: 100 → 50 participants

2026-08-13

Trial sites reduced: 53 → 48 locations

Trial Details

NCT Number	NCT06045754
Lead Sponsor	Takeda
Conditions	Crohn's Disease
Enrollment	50 participants
Start Date	2024-04-18
Primary Completion	2027-06-28 (estimated)
Study Completion	2027-06-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-31