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

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.

Timeline

Start

2025-01-02

Primary completion

2027-06-08

Completion

2028-08-01

Publications

• Danese S, Sands BE, Feagan BG, Jairath V, Panaccione R, Peyrin-Biroulet L, Irving PM, Schreiber S, Dotan I, Ferrante M, D'Haens GR, Jones S, Freire M, Lindner D, Adsul S, Oberai P, Colombel JF. Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease. Contemp Clin Trials Commun. 2025 Nov 24;48:101574. doi: 10.1016/j.conctc.2025.101574. eCollection 2025 Dec.

Drugs

Indications