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

RECRUITING

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

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

NCT07245394•TIDHI Innovation Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (9)

MA MacMillan

Fredericton, New Brunswick, Canada

Barrie GI Associates

Barrie, Ontario, Canada

Brampton Gastroenterology Research Group Inc

Brampton, Ontario, Canada

GNRR Digestive Clinics and Research Center Inc.

Brampton, Ontario, Canada

LDDI Clinical Trials Inc. dba London Digestive Disease Institute

London, Ontario, Canada

West Gta Research Inc.

Mississauga, Ontario, Canada

Abp Research Services Corporation

Oakville, Ontario, Canada

Taunton Surgical Center

Oshawa, Ontario, Canada

Toronto Immune and Digestive Health Institute

Toronto, Ontario, Canada

Key Dates

Start Date

January 29, 2026

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2028

Last Updated

February 12, 2026

Enrollment

200

ESTIMATED participants

Conditions

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

Interventions

Guselkumab (Tremfya)

BIOLOGICAL

Contacts

Ajani Jeyakumar, HBSc BScN RN

CONTACT

647-812-2113 ajeyakumar@tidhi.ca

Katy Staikin, MSc

CONTACT

647-812-2113 kstaikin@tidhi.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

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