Following people with active IBD who switch from ustekinumab to guselkumab
Follows adults with active IBD switching to guselkumab after ustekinumab.
Plain-language title generated from the registry record
Registry title: Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
Key facts
- Where
- Barrie, Brampton, Calgary, Fredericton, Hamilton, London, Mississauga, Montreal, Oakville, Oshawa, and Toronto, CanadaSee the 14 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active inflammatory bowel disease (Crohn's disease or ulcerative colitis) who did not respond well enough to ustekinumab and are starting guselkumab.
- Age
- 18 years or older
- Sex
- All genders can join
- Disease stage
- Crohn's disease, ulcerative colitis or IBD-unclassified, diagnosed at least 6 months ago, with signs of active disease on a colonoscopy within the last 3 months
- Earlier treatment
- Must have had ustekinumab for at least 14 weeks, still taking it or stopped within the last 12 weeks, with no other advanced therapy started since. Must not have had risankizumab or mirikizumab.
- Biomarker or test result
- Colonoscopy score showing active disease: SES-CD of 6 or more (4 or more if only the ileum is affected) or ulcers larger than 5 mm for Crohn's disease; UCEIS of 4 or more or erosions or ulcers for ulcerative colitis
Main reasons for not taking part
- Ostomy or ileo-anal pouch
- Bowel surgery within the last 6 months, or expected bowel surgery within the year
- History of colonic dysplasia or colorectal cancer
- Taking 1 or more other biologic drugs at the same time
- Contraindication to guselkumab, or unwilling to have a lower endoscopy
Read by machine on 9 November 2026.
Where in Canada
- Barrie GI AssociatesBarrie, CanadaContact: Anusha KallepalliTaking people
- Brampton Gastroenterology Research Group IncBrampton, CanadaContact: Shinderpal, KansaryTaking people
- GNRR Digestive Clinics and Research Center Inc.Brampton, CanadaContact: Kuljinder KaurTaking people
- University Of CalgaryCalgary, CanadaContact: Ana D'Aubeterre, MScTaking people
- MA MacMillanFredericton, CanadaContact: Mark MacMillan, MD, FRCPC, CAGFTaking people
- Hamilton Health Sciences CorporationHamilton, CanadaContact: Jaimin PatelNot yet recruiting
- LDDI Clinical Trials Inc. dba London Digestive Disease InstituteLondon, CanadaContact: Beth Beauchamp, RN, BScNTaking people
- West Gta Research Inc.Mississauga, CanadaContact: Nausheen AfrozTaking people
- Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, CanadaContact: Karine PaupertTaking people
- CIUSSS l'Est-de-l'Île-de-MontréalMontreal, CanadaContact: Stefania ChituNot yet recruiting
- The Research Institute of the McGill University Health CentreMontreal, CanadaContact: Pascale GermainTaking people
- Abp Research Services CorporationOakville, CanadaContact: Gabriela OliveiraTaking people
- Taunton Surgical CenterOshawa, CanadaContact: Alana Carter, BSN, MNTaking people
- Toronto Immune and Digestive Health InstituteToronto, CanadaContact: Kaitlyn Mitchell, RN, BScN, MScTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- TIDHI Innovation Inc.
- Trial code
- NCT07245394
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD
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.
Inclusion: Subjects of any gender aged ≥ 18; Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%; Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy; For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab; Subjects with an inadequate response to ustekinumab who require a change in advanced therapy and are initiating guselkumab, as determined by the treating physician; For subjects on off-label ustekinumab dosing (90 mg every 4 or 6 weeks (off-label dosing), enrollment will be capped at 60%; Ability and willingness to give written informed consent and comply with the requirements of this study protocol; Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as:; For Crohn's Disease: Colonoscopy showing SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), OR presence of ulcers larger than 5 mm in any segment; For Ulcerative Colitis: Colonoscopy showing Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≥4, OR presence of erosions or ulcers in any segment.
Exclusion: History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab); Subjects with formal contraindication to guselkumab per the drug label; Subjects with a history of bowel surgery within 6 months prior to Week 0; Subjects displaying clinical signs of acute severe UC, fulminant colitis or toxic megacolon within 3 months prior to Week 0; Subjects who are expected to require bowel surgery by their IBD physician within the year of enrollment; Subjects on 1 or more concomitant biologics; Subjects with a history of colonic dysplasia (low-grade dysplasia, high-grade dysplasia, or colorectal cancer). Note: Patients with a history of indefinite for dysplasia would be eligible; Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded; Subjects with an ostomy or ileo-anal pouch; Subjects with formal contraindication or unwilling to undergo lower endoscopy; The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.