Switching to High-efficacy anti-Il-23 biologic From usTekinumab in active IBD
Study Status: Start-up and protocol development.
Principal Investigators: Dr. Laura Targownik and Dr. Pablo A. Olivera Sendra
Co-Investigators
Dr. Parul Tandon
Primary Objectives
Aim 1: to define short- and mid-term clinical, biochemical, and endoscopic response rates of anti-p19 inhibitors in patients with objectively active IBD who are either on maintenance therapy with ustekinumab or have been previously exposed to ustekinumab, and to determine clinical predictors of response.
Aim 2: to characterize the real-world safety profile of anti-p19 inhibitors in patients with previous exposure to ustekinumab and objectively active IBD.
Aim 3: to determine changes in quality of life (QoL) and mental health measures after switching from ustekinumab to anti-p19 inhibitors.
Study Design
The SHIFT-IBD study will be a multicentre, prospective, cohort study that will follow patients with objective evidence of ongoing IBD activity despite current or previous ustekinumab treatment who are being switched to an anti-p19 inhibitor (i.e., guselkumab, risankizumab, mirikizumab), who will be followed for up to 12 months. Enrolled subjects will be assessed for clinical, endoscopic, and biochemical improvement and/or relapse, Patients will be managed by their physicians otherwise as per the usual standard of care (SoC).
Participating Sites
TBD
Targets
Anticipated sample size: 107 participants
Anticipated start date: 2025
Anticipated end: 2028