Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for IBD patients: switching to guselkumab after ustekinumab fails

NCT ID NCT07245394

Disease control Sponsor: TIDHI Innovation Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This Canadian study is testing whether switching to the drug guselkumab (Tremfya) can help people with inflammatory bowel disease (IBD) who didn't respond well enough to ustekinumab. Researchers will track symptoms, test results, and overall health in 200 participants over one year. The goal is to see if this switch can lead to better disease control without worsening endoscopic findings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Guselkumab (Tremfya)
What this could lead to
If successful, this could show that switching to guselkumab is a good option for people with IBD who didn't get enough relief from ustekinumab, offering better symptom control.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It's also relatively small (200 people) and only follows participants for one year, so long-term benefits or risks are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

IBD patients who had inadequate response to ustekinumab and switched therapy to guselkumab.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn disease (CD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Crohn disease indeterminate colitis inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) IBD-unclassified (IBD-U) Inflammatory bowel disease (IBD) Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abp Research Services Corporation

    RECRUITING

    Oakville, Ontario, L6L 5L7, Canada

  • Barrie GI Associates

    RECRUITING

    Barrie, Ontario, L4M 7G1, Canada

    Contact Email: •••••@•••••

  • Brampton Gastroenterology Research Group Inc

    RECRUITING

    Brampton, Ontario, L6S 0C1, Canada

    Contact Email: •••••@•••••

  • CIUSSS l'Est-de-l'Île-de-Montréal

    NOT_YET_RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    RECRUITING

    Montreal, Quebec, Canada

  • GNRR Digestive Clinics and Research Center Inc.

    RECRUITING

    Brampton, Ontario, L6S 0E2, Canada

    Contact Email: •••••@•••••

  • Hamilton Health Sciences Corporation

    NOT_YET_RECRUITING

    Hamilton, Ontaio, L8L 2X2, Canada

  • LDDI Clinical Trials Inc. dba London Digestive Disease Institute

    RECRUITING

    London, Ontario, N6K 1M6, Canada

  • MA MacMillan

    RECRUITING

    Fredericton, New Brunswick, E3B 1J5, Canada

  • Taunton Surgical Center

    RECRUITING

    Oshawa, Ontario, L1J 0C7, Canada

  • The Research Institute of the McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • Toronto Immune and Digestive Health Institute

    RECRUITING

    Toronto, Ontario, M6A3B4, Canada

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 4Z6, Canada

  • West Gta Research Inc.

    RECRUITING

    Mississauga, Ontario, L5M 2S4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.