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

Sponsor
TIDHI Innovation Inc.
Study ID
NCT07245394
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
Feb 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Rate of participants achieving deep remission in IBD patients treated with guselkumab after switching from ustekinumab [ Time Frame: Week 52 ]

Central Contacts

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