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
Dr. Sahar Tabatabavakili
Dr. Vivian Huang
Dr. Alexa Sasson
Primary Objectives
Aim 1: to define short- and mid-term clinical, biochemical, and endoscopic response rates to risankizumab after switching from ustekinumab in patients with objectively active CD, and to determine clinical predictors of response.
Aim 2: to characterize the real-world safety profile of risankizumab after switching from ustekinumab in patients with objectively active CD.
Aim 3: to determine changes in quality of life (QoL) and mental health measures after switching from ustekinumab to risankizumab.
Study Design
The SHIFT-IBD study will be a multicentre, prospective, cohort study that will follow patients with objective evidence of ongoing CD activity despite current or previous ustekinumab treatment. The study will be comprised of two cohorts:
COHORT A (risankizumab switch cohort): patients with active CD on ustekinumab maintenance or who stopped ustekinumab within 6 months, who are then switched to risankizumab.
COHORT B (ustekinumab continuation cohort): patients with active CD on ustekinumab maintenance at screening and who are maintained on ustekinumab due to patient or physician choice. This cohort will serve as a reference group. Patients enrolled in cohort B could crossover into cohort A if the patient is considered for switching treatment from ustekinumab to risankizumab during follow-up.
These cohorts will be followed for up to 12 months, and assessed for clinical, endoscopic, and biochemical improvement and/or relapse, with rates compared between the two cohorts, adjusted for differences in baseline characteristics. 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: 2024
Anticipated end: 2027