ClinicalTrials.gov
Cure8 trial brief
Why This Matters
People with IBD who don’t respond well to ustekinumab may need alternative options. This study will track how patients fare after switching to guselkumab in routine clinical care and report rates of deep remission at one year.
Who Should Pay Attention
Adult IBD patients (Crohn’s disease, ulcerative colitis, IBD‑U) who have had an inadequate response to ustekinumab, clinicians who manage biologic switching, and researchers studying biologic sequencing.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment200 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a recruiting observational study (SHIFT-IBD) in Canada enrolling adults with active IBD (Crohn’s, UC, or IBD-U) who had an inadequate response to ustekinumab and are switching to guselkumab (Tremfya) as part of routine care.
Participants are followed for one year with symptom and test monitoring; the primary outcome is deep remission at Week 52, defined as no symptomatic worsening plus endoscopic remission.
The study enrolls two cohorts: an Early Switch Cohort (patients on standard on‑label ustekinumab maintenance dosing) and an Exhausted Ustekinumab Cohort (patients who had off‑label more frequent ustekinumab dosing). Patients start guselkumab per local clinical practice and their treating physician may adjust therapy as needed.
This is an observational registry-style study rather than a randomized trial; it will describe outcomes after switching in real‑world practice and exclude people previously exposed to anti‑p19 drugs (risankizumab or mirikizumab) or those on concurrent biologics.
If you’re considering switching therapies, note that this study is not testing guselkumab versus another drug in a randomized way; it aims to collect real‑world data on response after switching from ustekinumab.
Keep In Mind
This is an observational, non-randomized study recording outcomes when clinicians switch patients to guselkumab per usual care; results will reflect real‑world practice rather than controlled trial conditions. The registry excludes patients with prior anti‑p19 exposure and certain surgical or severe disease states.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorTIDHI Innovation Inc.
Trial IDNCT07245394
Study typeObservational
Enrollment200 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 31, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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