Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) (SHIFT-IBD)

February 10, 2026 updated by: TIDHI Innovation Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1J5
        • Recruiting
        • MA MacMillan
        • Contact:
          • Mark MacMillan, MD, FRCPC, CAGF
          • Phone Number: (506)454-6682
          • Email: mamacmil@me.com
        • Principal Investigator:
          • Mark MacMilan, MD, FRCPC, CAGF
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • Barrie GI Associates
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lindsay Crabbe, MD
      • Brampton, Ontario, Canada, L6S 0E2
        • Recruiting
        • GNRR Digestive Clinics and Research Center Inc.
        • Contact:
          • Stella Rho, MHSc CCRP PMP
          • Phone Number: 647-812-2113
          • Email: srho@tidhi.ca
        • Contact:
        • Principal Investigator:
          • Girish Bajaj, MD
      • Brampton, Ontario, Canada, L6S 0C1
      • London, Ontario, Canada, N6K 1M6
        • Not yet recruiting
        • LDDI Clinical Trials Inc. dba London Digestive Disease Institute
        • Contact:
        • Principal Investigator:
          • Vipul Jairath, MD
      • Mississauga, Ontario, Canada, L5M 2S4
      • Oakville, Ontario, Canada, L6L 5L7
        • Recruiting
        • Abp Research Services Corporation
        • Principal Investigator:
          • Naveen Arya, MD
        • Contact:
        • Contact:
      • Oshawa, Ontario, Canada, L1J 0C7
        • Recruiting
        • Taunton Surgical Center
        • Principal Investigator:
          • Daniel Green, MD
        • Contact:
      • Toronto, Ontario, Canada, M6A3B4
        • Recruiting
        • Toronto Immune and Digestive Health Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petros Zesos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

IBD patients who had inadequate response to ustekinumab and switched therapy to guselkumab.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: Guselkumab (Tremfya)
Switching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab.
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.
Biological: Guselkumab (Tremfya)
Switching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants achieving symptomatic remission among those not in remission at baseline
Time Frame: Week 12 and Week 52
Week 12 and Week 52
Rate of participants achieving steroid-free remission among corticosteroid users at baseline
Time Frame: Week 52
Steroid-free remission defined as no corticosteroid use and meeting symptomatic remission criteria
Week 52
Rate of participants discontinuing guselkumab therapy
Time Frame: Any study visit (Week 4, Week 12, Week 32, Week 52)
Any study visit (Week 4, Week 12, Week 32, Week 52)
Rate of participants with absence of symptomatic worsening
Time Frame: Week 52

Absence of symptomatic worsening defined as the absence of:

  1. 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.
  2. 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.
Week 52
Rate of participants achieving endoscopic remission
Time Frame: Week 52

Endoscopic remission is defined as follows:

  1. 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.
  2. 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.
Week 52
Rate of participants achieving endoscopic response
Time Frame: Week 52

Endoscopic response is defined as follows:

  1. 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).
  2. For ulcerative colitis: A reduction of 2 points or more in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) compared to baseline.
Week 52
Rate of participants with absence of symptomatic worsening
Time Frame: Any study visit (Week 4, Week 12, Week 32, Week 52)

Absence of symptomatic worsening defined as the absence of:

  1. 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.
  2. 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.
Any study visit (Week 4, Week 12, Week 32, Week 52)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants achieving biochemical remission
Time Frame: Week 52

Biochemical remission at among patients with available fecal calprotectin (FCAL) and C-reactive protein (CRP).

Biochemical remission is defined as FCAL ≤250 ug/g AND a CRP ≤5 mg/L among patients with available either an elevated FCAL or CRP at baseline.
Week 52
Rate of participants achieving biochemical remission
Time Frame: Week 12

Biochemical remission at among patients with available fecal calprotectin (FCAL) and C-reactive protein (CRP).

Biochemical remission is defined as FCAL ≤250 ug/g AND a CRP ≤5 mg/L among patients with available either an elevated FCAL or CRP at baseline.
Week 12
Change from baseline in quality of life
Time Frame: Week 52

Quality of Life (QoL) outcomes will be reported as the change from baseline, using the following assessments:

EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L): This tool evaluates five dimensions of health, each rated on a scale from 1 to 5. Higher scores indicate worse health status.

Short Form Health Survey (SF-36): This questionnaire measures eight health domains, with each domain scored from 0 to 100. Higher scores reflect better health status.
Week 52
Change from baseline in work productivity
Time Frame: Week 52
Work Productivity outcomes will be reported as the change from baseline, assessed using the Work Productivity and Activity Impairment questionnaires specific to Crohn's disease (WPAI-CD) and ulcerative colitis (WPAI-UC). Scores range from 0 to 100 percent, with higher percentages indicating greater impairment in work and daily activities.
Week 52
Change from baseline in mental health (anxiety)
Time Frame: Week 52
Mental Health (anxiety) outcomes will be reported as the change from baseline, assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7): Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Week 52
Change from baseline in mental health (depression)
Time Frame: Week 52
Mental Health (depression) outcomes will be reported as the change from baseline, assessed using the Patient Health Questionnaire-9 (PHQ-9): Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Week 52
Change from baseline in fatigue
Time Frame: Week 52
Fatigue outcomes will be reported as the change from baseline, assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F). Scores range from 0 to 52, with higher scores indicating less fatigue and better functioning.
Week 52
Rate of participants achieving early symptomatic response among those not in symptomatic remission at baseline
Time Frame: Week 4

Early symptomatic response at week 4 among patients who were not in symptomatic remission at baseline is defined as follows:

  1. For Crohn's disease: A decrease of 30 percent or more in the average daily stool frequency score (SFS) and/or a decrease of 30 percent or more in the average daily abdominal pain score (APS), with both scores not worse than Baseline.
  2. 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.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TIDHI Innovation Inc.

Collaborators

Janssen Inc.

Investigators

  • Principal Investigator: Laura E. Targownik, MD, MSHS, FRCPC, TIDHI Innovation Inc.
  • Principal Investigator: Mark Silverberg, MD, PhD, FRCPC, TIDHI Innovation Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIDHI_001
  • ISRCTN13202059 (Registry Identifier: ISRCTN Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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