Inflammatory Bowel Disease (IBD)SHIFT-IBDNCT07245394
Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
An observational study of Inflammatory Bowel Disease (IBD) and Crohn Disease (CD), run by TIDHI Innovation Inc. at 14 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Guselkumab (Tremfya)
- How many people
- 200 participants
- Where
- 14 sitesCanada
- Study dates
- 29 Jan 2026to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients who had inadequate response to ustekinumab and switched therapy to guselkumab.
Who may be able to join
- 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%.
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- 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.
Who cannot join
- History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).
- Subjects with formal contraindication to guselkumab per the drug label.
- 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 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.
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- 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.
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Canada14 sites, 14 recruiting
- Recruiting
Barrie GI Associates
Barrie, Ontario, L4M 7G1
Anusha Kallepalli, 705-721-3344 ext. 155, anushak@barriegi.ca
Colayna Harris-Mailloux, RN, BScN, 705-721-3344 ext. 155, researchclinic@barriegi.ca
- Recruiting
Brampton Gastroenterology Research Group Inc
Brampton, Ontario, L6S 0C1
Shinderpal, Kansary, clinicalrn@bramptongiresearch.onmicrosoft.com
Stella Rho, MHSc CCRP PMP, 647-812-2113, srho@tidhi.ca
- Recruiting
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, L6S 0E2
Kuljinder Kaur, researchnurse@gnrr.ca
Stella Rho, MHSc CCRP PMP, 647-812-2113, srho@tidhi.ca
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
Ana D'Aubeterre, MSc, 587-894-1134, ana.daubeterre@ucalgary.ca
Joëlle St-Pierre, MD
- Recruiting
MA MacMillan
Fredericton, New Brunswick, E3B 1J5
Mark MacMillan, MD, FRCPC, CAGF, (506)454-6682, mamacmil@me.com
Mark MacMilan, MD, FRCPC, CAGF
- Not yet recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontaio, L8L 2X2
Jaimin Patel, 905-521-2100, patej102@mcmaster.ca
Neeraj Narula, MD
- Recruiting
LDDI Clinical Trials Inc. dba London Digestive Disease Institute
London, Ontario, N6K 1M6
Beth Beauchamp, RN, BScN, (519) 204-6333, bbeauchamp@lddi.ca
Vipul Jairath, MD
- Recruiting
West Gta Research Inc.
Mississauga, Ontario, L5M 2S4
Nausheen Afroz, 905-823-0223 ext. 111, nausheen.afroz@wgtaresearch.com
Lidia Lepore, lidia.lepore@wgtaresearch.com
- Not yet recruiting
CIUSSS l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
Stefania Chitu, (514) 252-3400 ext. 3116, schitu.hmr@ssss.gouv.qc.ca
Valérie Héron, MD
- Recruiting
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3G 1A4
Pascale Germain, 514-934-1934, pascale.germain@muhc.mcgill.ca
Waqqas Afif, MD
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Karine Paupert, 514-890-8000 ext. 21437, karine.paupert.chum@ssss.gouv.qc.ca
Robert Battat, MD
- Recruiting
Abp Research Services Corporation
Oakville, Ontario, L6L 5L7
Gabriela Oliveira, 289-863-1112, otmh.research@theoec.ca
Hakimat Shaibu, MSc, 289-863-1112, hakimat.shaibu@theoec.ca
- Recruiting
Taunton Surgical Center
Oshawa, Ontario, L1J 0C7
Alana Carter, BSN, MN, 905-723-8551 ext. 5444, alanacarter01@gmail.com
Daniel Green, MD
- Recruiting
Toronto Immune and Digestive Health Institute
Toronto, Ontario, M6A3B4
Kaitlyn Mitchell, RN, BScN, MSc, 647-812-2113, kmitchell@tidhi.ca
Janet Saad, 647-812-2113, mschwartz@tidhi.ca
About this study
Official title: 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.
Read more
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
- Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
- Being tested
- Guselkumab (Tremfya)
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab (Tremfya)Biological
Switching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab.
| Study group | Role | What they receive |
|---|---|---|
| Early Switch Cohort (ESC) | Patients with CD or UC who had inadequate response to on-label maintenance ustekinumab (90 mg every 8 weeks) that requires a change in advanced therapy, as determined by the treating physician. Inadequate response could be either loss of response, partial response, or persistent endoscopic activity. Receives: Biological: Guselkumab (Tremfya) | |
| Exhausted Ustekinumab Cohort (EUC) | Patients with CD or UC who had inadequate response to off-label maintenance ustekinumab (90 mg every 6 or 4 weeks) that requires a change in advanced therapy, as determined by the treating physician. Inadequate response could be either loss of response, partial response, or persistent endoscopic activity. Receives: Biological: Guselkumab (Tremfya) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants achieving deep remission in IBD patients treated with guselkumab after switching from ustekinumab
Deep remission is defined as both absence of symptomatic worsening and endoscopic remission.
Outcomes will be reported as the proportion of participants achieving deep remission at Week 52.
Measured: Week 52
Rate of participants achieving deep remission, stratified by cohorts
Deep remission is defined as both absence of symptomatic worsening and endoscopic remission.
Outcomes will be reported as the proportion of participants achieving deep remission at Week 52 and stratified by Early Switch Cohort (ESC) and Exhausted Ustekinumab Cohort (EUC).
Measured: Week 52
Secondary outcomes (7)
Rate of participants with absence of symptomatic worsening
Absence of symptomatic worsening defined as the absence of:
- For Crohn's disease: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily abdominal pain score (APS) compared to Baseline.
- For ulcerative colitis: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily rectal bleeding score (RBS) compared to Baseline.
Measured: Week 52
Rate of participants achieving endoscopic remission
Endoscopic remission is defined as follows:
- For Crohn's disease: A Simple Endoscopic Score for Crohn's Disease (SDS-CD) of 4 or less, or a score of 2 or less in the ileal segment (excluding the narrowing component) in cases of disease limited to the ileum, with an ulceration subscore of 0.
- For ulcerative colitis: A Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 1 or less, with a bleeding subscore of 0 and an erosions/ulcers subscore of 0.
Measured: Week 52
Rate of participants achieving endoscopic response
Endoscopic response is defined as follows:
- For Crohn's disease: A reduction of 50 percent or more in the Simple Endoscopic Score for Crohn's Disease (SDS-CD) compared to Baseline (excluding the narrowing component).
- For ulcerative colitis: A reduction of 2 points or more in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) compared to baseline.
Measured: Week 52
Rate of participants with absence of symptomatic worsening
Absence of symptomatic worsening defined as the absence of:
- For Crohn's disease: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily abdominal pain score (APS) compared to the baseline value.
- For ulcerative colitis: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily rectal bleeding score (RBS) compared to Baseline.
Measured: Any study visit (Week 4, Week 12, Week 32, Week 52)
Rate of participants achieving symptomatic remission among those not in remission at baseline
Measured: Week 12 and Week 52
Rate of participants achieving steroid-free remission among corticosteroid users at baseline
Steroid-free remission defined as no corticosteroid use and meeting symptomatic remission criteria
Measured: Week 52
Rate of participants discontinuing guselkumab therapy
Measured: Any study visit (Week 4, Week 12, Week 32, Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start29 Jan 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TIDHI Innovation Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Sponsor
- Investigators
- Laura E. Targownik, MD, MSHS, FRCPC, Principal investigator, TIDHI Innovation Inc.Mark Silverberg, MD, PhD, FRCPC, Principal investigator, TIDHI Innovation Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245394
- Sponsor's protocol ID
- TIDHI_001
- Other IDs
- ISRCTN13202059
- Acronym
- SHIFT-IBD
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD
- ClinicalTrials.gov ID
- NCT07245394
- Acronym / sponsor ID
- SHIFT-IBD / TIDHI_001
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TIDHI Innovation Inc.University, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Switch Cohort (ESC) | – | Biological: Guselkumab (Tremfya)Patients with CD or UC who had inadequate response to on-label maintenance ustekinumab (90 mg every 8 weeks) that requires a change in advanced therapy, as determined by the treating physician. Inadequate response could be either loss of response, partial response, or persistent endoscopic activity. |
| Exhausted Ustekinumab Cohort (EUC) | – | Biological: Guselkumab (Tremfya)Patients with CD or UC who had inadequate response to off-label maintenance ustekinumab (90 mg every 6 or 4 weeks) that requires a change in advanced therapy, as determined by the treating physician. Inadequate response could be either loss of response, partial response, or persistent endoscopic activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients who had inadequate response to ustekinumab and switched therapy to guselkumab.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).
- Subjects with formal contraindication to guselkumab per the drug label.
- 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 a history of bowel surgery within 6 months prior to Week 0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guselkumab (Tremfya)Switching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab. | Biological | Early Switch Cohort (ESC), Exhausted Ustekinumab Cohort (EUC) |
Primary outcome
Rate of participants achieving deep remission in IBD patients treated with guselkumab after switching from ustekinumab
Time frame: Week 52
Deep remission is defined as both absence of symptomatic worsening and endoscopic remission. Outcomes will be reported as the proportion of participants achieving deep remission at Week 52.
Rate of participants achieving deep remission, stratified by cohorts
Time frame: Week 52
Deep remission is defined as both absence of symptomatic worsening and endoscopic remission. Outcomes will be reported as the proportion of participants achieving deep remission at Week 52 and stratified by Early Switch Cohort (ESC) and Exhausted Ustekinumab Cohort (EUC).
7 secondary outcomes
Rate of participants with absence of symptomatic worsening
Time frame: Week 52
Rate of participants achieving endoscopic remission
Time frame: Week 52
Rate of participants achieving endoscopic response
Time frame: Week 52
Rate of participants with absence of symptomatic worsening
Time frame: Any study visit (Week 4, Week 12, Week 32, Week 52)
Rate of participants achieving symptomatic remission among those not in remission at baseline
Time frame: Week 12 and Week 52
Rate of participants achieving steroid-free remission among corticosteroid users at baseline
Time frame: Week 52
Rate of participants discontinuing guselkumab therapy
Time frame: Any study visit (Week 4, Week 12, Week 32, Week 52)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura E. Targownik, MD, MSHS, FRCPC principal investigator
TIDHI Innovation Inc.
Mark Silverberg, MD, PhD, FRCPC principal investigator
TIDHI Innovation Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Crohn Disease (CD), run by TIDHI Innovation Inc. at 14 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajani Jeyakumar, HBSc BScN RN (647-812-2113, ajeyakumar@tidhi.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants achieving deep remission in IBD patients treated with guselkumab after switching from ustekinumab (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.