Vedolizumab + Upadacitinib for Crohn's Disease
(VICTRIVA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy, which might imply changes to current treatments.
What data supports the effectiveness of the drugs Vedolizumab and Upadacitinib for Crohn's Disease?
What safety data exists for Vedolizumab and Upadacitinib in humans?
Upadacitinib was found to be well-tolerated over 30 months in patients with Crohn's disease. Vedolizumab has been associated with some adverse events, including serious ones, but is generally considered safe for Crohn's disease and ulcerative colitis, with longer-term studies needed to fully understand its safety profile.56789
How is the drug combination of Vedolizumab and Upadacitinib unique for treating Crohn's Disease?
This treatment is unique because it combines Vedolizumab, a biologic drug that targets specific proteins involved in gut inflammation, with Upadacitinib, an oral medication that inhibits Janus kinase (JAK), a protein involved in immune response. This combination may offer a novel approach by targeting different pathways in the immune system compared to other treatments.13101112
What is the purpose of this trial?
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.
Research Team
Study Director
Principal Investigator
Takeda
Eligibility Criteria
Adults with moderately to severely active Crohn's Disease who haven't responded well to or can't tolerate corticosteroids, immunomodulators, or biologics. They must have a confirmed diagnosis for at least 3 months and show bowel inflammation on specific tests.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive vedolizumab and upadacitinib or vedolizumab and placebo for 12 weeks
Maintenance
Participants who respond to induction treatment receive vedolizumab monotherapy for 40 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Upadacitinib
- Vedolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Universitรฉ de Montpellier