Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease.

ABSTRACT:

Introduction

Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.

Methods

The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q

SUBMITTER: Danese S 

PROVIDER: S-EPMC12703854 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature