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

Crohn's Disease Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-week Induction Period:

• Induction Period: Vedolizumab + Upadacitinib

• Induction Period: Vedolizumab + Placebo

Participants who achieve a Crohn's disease activity index (CDAI) reduction of ≥70 points from baseline at Week 12 will progress into the 40-week Maintenance Period of the study to receive vedolizumab monotherapy. Participants will be followed for a further 18-week safety follow-up period up to Week 70.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks. ;

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

• NCT number: NCT06227910
• Study type: Interventional
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS@takeda.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 22, 2024
• Completion date: August 1, 2028