Clinical Trial

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Study acronym: VICTRIVA
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.
Trial Details
NCT Number NCT06227910
Lead Sponsor Takeda
Conditions Crohn's Disease
Enrollment 396 participants
Start Date 2025-01-02
Primary Completion 2027-06-08 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27