Actively Recruiting
Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
Led by TIDHI Innovation Inc. · Updated on 2026-02-12
200
Participants Needed
9
Research Sites
143 weeks
Total Duration
On this page
Sponsors
T
TIDHI Innovation Inc.
Lead Sponsor
J
Janssen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab. Patients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year. Guselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care. Researchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy. The goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.
CONDITIONS
Official Title
Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of inflammatory bowel disease (Crohn disease, ulcerative colitis, or IBD-unclassified) for at least 6 months
- Received ustekinumab for at least 14 weeks or recently discontinued ustekinumab (within 12 weeks before study start)
- No other advanced therapy started after stopping ustekinumab
- Inadequate response to ustekinumab requiring change to guselkumab treatment
- Enrollment capped at 75% for Crohn disease patients and 60% for off-label ustekinumab dosing
- Willing and able to give written informed consent and comply with study requirements
- Evidence of ongoing endoscopic disease activity within 3 months prior to study start, defined by specific colonoscopy findings for Crohn disease or ulcerative colitis
You will not qualify if you...
- Previous exposure to any anti-p19 inhibitor (risankizumab or mirikizumab)
- Contraindication to guselkumab per drug label
- Use of guselkumab for off-label indication, dosing, or administration route
- No guselkumab induction received
- Presence of ostomy or ileo-anal pouch
- History of bowel surgery within 6 months prior to study start
- Clinical signs of acute severe ulcerative colitis, fulminant colitis, or toxic megacolon within 3 months prior to study start
- Expected to require bowel surgery within the study year
- Use of one or more concomitant biologic therapies
- History of colonic dysplasia or colorectal cancer (except indefinite dysplasia)
- Contraindication or unwillingness to undergo lower endoscopy
- Investigator considers the patient unsuitable for the study for any reason
AI-Screening
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Trial Site Locations
Total: 9 locations
1
MA MacMillan
Fredericton, New Brunswick, Canada, E3B 1J5
Actively Recruiting
2
Barrie GI Associates
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
3
Brampton Gastroenterology Research Group Inc
Brampton, Ontario, Canada, L6S 0C1
Actively Recruiting
4
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada, L6S 0E2
Actively Recruiting
5
LDDI Clinical Trials Inc. dba London Digestive Disease Institute
London, Ontario, Canada, N6K 1M6
Not Yet Recruiting
6
West Gta Research Inc.
Mississauga, Ontario, Canada, L5M 2S4
Actively Recruiting
7
Abp Research Services Corporation
Oakville, Ontario, Canada, L6L 5L7
Actively Recruiting
8
Taunton Surgical Center
Oshawa, Ontario, Canada, L1J 0C7
Actively Recruiting
9
Toronto Immune and Digestive Health Institute
Toronto, Ontario, Canada, M6A3B4
Actively Recruiting
Research Team
A
Ajani Jeyakumar, HBSc BScN RN
CONTACT
K
Katy Staikin, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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