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

NCT07245394 | Recruiting

• 2 other identifiers: TIDHI_001ISRCTN13202059
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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. 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

Inflammatory Bowel Disease (IBD); Crohn Disease (CD); Ulcerative Colitis (UC); IBD-unclassified (IBD-U)

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Week 52

Secondary Outcomes (7)

• Rate of participants with absence of symptomatic worsening

  Week 52

• Rate of participants achieving endoscopic remission

  Week 52

• Rate of participants achieving endoscopic response

  Week 52

• Rate of participants with absence of symptomatic worsening

  Any study visit (Week 4, Week 12, Week 32, Week 52)

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

  Week 12 and Week 52

Other Outcomes (8)

• Rate of participants achieving early symptomatic response among those not in symptomatic remission at baseline

  Week 4

• Rate of participants achieving biochemical remission

  Week 52

• Rate of participants achieving biochemical remission

  Week 12

Study Arms (2)

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)

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)

Interventions

Guselkumab (Tremfya) BIOLOGICAL

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

Early Switch Cohort (ESC); Exhausted Ustekinumab Cohort (EUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TIDHI Innovation Inc.: lead
• Janssen Inc.: collaborator

Study Sites (9)

MA MacMillan

Fredericton, New Brunswick, E3B 1J5, Canada

RECRUITING

Barrie GI Associates

Barrie, Ontario, L4M 7G1, Canada

RECRUITING

Brampton Gastroenterology Research Group Inc

Brampton, Ontario, L6S 0C1, Canada

RECRUITING

GNRR Digestive Clinics and Research Center Inc.

Brampton, Ontario, L6S 0E2, Canada

RECRUITING

LDDI Clinical Trials Inc. dba London Digestive Disease Institute

London, Ontario, N6K 1M6, Canada

NOT YET RECRUITING

West Gta Research Inc.

Mississauga, Ontario, L5M 2S4, Canada

RECRUITING

Abp Research Services Corporation

Oakville, Ontario, L6L 5L7, Canada

RECRUITING

Taunton Surgical Center

Oshawa, Ontario, L1J 0C7, Canada

RECRUITING

Toronto Immune and Digestive Health Institute

Toronto, Ontario, M6A3B4, Canada

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Laura E. Targownik, MD, MSHS, FRCPC

  TIDHI Innovation Inc.

  PRINCIPAL INVESTIGATOR

• Mark Silverberg, MD, PhD, FRCPC

  TIDHI Innovation Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajani Jeyakumar, HBSc BScN RN

CONTACT

647-812-2113; ajeyakumar@tidhi.ca

Katy Staikin, MSc

CONTACT

647-812-2113; kstaikin@tidhi.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 24, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CA (9)