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

NCT07245394 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-02-12

No results posted yet for this study

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)

Interventions

BIOLOGICAL

Guselkumab (Tremfya)

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

Sponsors & Collaborators

  • Janssen Inc.

    collaborator INDUSTRY

  • TIDHI Innovation Inc.

    lead OTHER

Principal Investigators

  • Laura E. Targownik, MD, MSHS, FRCPC · TIDHI Innovation Inc.

  • Mark Silverberg, MD, PhD, FRCPC · TIDHI Innovation Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2027-11-01
Completion
2028-11-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245394 on ClinicalTrials.gov