RecruitingNCT07245394

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


Sponsor

TIDHI Innovation Inc.

Enrollment

200 participants

Start Date

Jan 29, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether switching from ustekinumab to guselkumab (both are biologic drugs that target inflammation) works well for people with inflammatory bowel disease (IBD — including Crohn's disease and ulcerative colitis) who are no longer responding well to ustekinumab. Both drugs work on similar immune pathways, but guselkumab is more specific. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis, or indeterminate colitis) for at least 6 months - You have been receiving ustekinumab for at least 16 weeks and still have active disease - You have not previously tried guselkumab **You may NOT be eligible if...** - You have recently had a serious infection or are at high risk of infection - You have active tuberculosis - You have a history of certain cancers - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGuselkumab (Tremfya)

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


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

View Full Details on ClinicalTrials.gov

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NCT07245394


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