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NCT Number: NCT07245394

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

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases IBD-unclassified (IBD-U) Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guselkumab (Tremfya)

Biological

Switching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Rate of participants with absence of symptomatic worsening

    Time frame: Week 52

    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.

  2. Rate of participants achieving endoscopic remission

    Time frame: Week 52

    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.

  3. Rate of participants achieving endoscopic response

    Time frame: Week 52

    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.

  4. 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:

    • 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.

  5. Rate of participants achieving symptomatic remission among those not in remission at baseline

    Time frame: Week 12 and Week 52

  6. 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

  7. Rate of participants discontinuing guselkumab therapy

    Time frame: Any study visit (Week 4, Week 12, Week 32, Week 52)

Other outcomes

  1. 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:

    • 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.
    • 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ajani Jeyakumar, HBSc BScN RN

CONTACT

[email protected]

647-812-2113

Katy Staikin, MSc

CONTACT

[email protected]

647-812-2113

Sponsors and collaborators

Lead sponsor

TIDHI Innovation Inc.

Other

Collaborators

  • Janssen Inc.

Registry information

Official study title

SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD

Acronym: SHIFT-IBD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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