Recruiting

Guselkumab

Sponsor:

TIDHI Innovation Inc.

Code:

NCT07245394

Conditions

Inflammatory Bowel Disease (IBD)

Crohn Disease (CD)

Ulcerative Colitis (UC)

IBD-unclassified (IBD-U)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Guselkumab (Tremfya)

Study Details

Brief 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)

Study ID

NCT07245394

Start date

Jan 29, 2026

Status verified date

Aug, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Guselkumab (Tremfya)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ajani Jeyakumar, HBSc BScN RN

647-812-2113ajeyakumar@tidhi.ca

Katy Staikin, MSc

647-812-2113kstaikin@tidhi.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Ana D'Aubeterre, MSc

587-894-1134ana.daubeterre@ucalgary.ca

Principal Investigator:

Joëlle St-Pierre, MD

MA MacMillan

Recruiting

Fredericton, New Brunswick, Canada, E3B 1J5

Contacts

Mark MacMillan, MD, FRCPC, CAGF

(506)454-6682mamacmil@me.com

Principal Investigator:

Mark MacMilan, MD, FRCPC, CAGF

Barrie GI Associates

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Contacts

Anusha Kallepalli

705-721-3344anushak@barriegi.ca

Colayna Harris-Mailloux, RN, BScN

705-721-3344researchclinic@barriegi.ca

Principal Investigator:

Lindsay Crabbe, MD

Brampton Gastroenterology Research Group Inc

Recruiting

Brampton, Ontario, Canada, L6S 0C1

Contacts

Shinderpal, Kansary

clinicalrn@bramptongiresearch.onmicrosoft.com

Stella Rho, MHSc CCRP PMP

647-812-2113srho@tidhi.ca

Principal Investigator:

Andrew Bellini, MD

GNRR Digestive Clinics and Research Center Inc.

Recruiting

Brampton, Ontario, Canada, L6S 0E2

Contacts

Kuljinder Kaur

researchnurse@gnrr.ca

Stella Rho, MHSc CCRP PMP

647-812-2113srho@tidhi.ca

Principal Investigator:

Girish Bajaj, MD

LDDI Clinical Trials Inc. dba London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

Contacts

Beth Beauchamp, RN, BScN

(519) 204-6333bbeauchamp@lddi.ca

Principal Investigator:

Vipul Jairath, MD

West Gta Research Inc.

Recruiting

Mississauga, Ontario, Canada, L5M 2S4

Contacts

Nausheen Afroz

905-823-0223nausheen.afroz@wgtaresearch.com

Lidia Lepore

lidia.lepore@wgtaresearch.com

Principal Investigator:

Callum Dargavel, MD

Abp Research Services Corporation

Recruiting

Oakville, Ontario, Canada, L6L 5L7

Contacts

Gabriela Oliveira

289-863-1112otmh.research@theoec.ca

Hakimat Shaibu, MSc

289-863-1112hakimat.shaibu@theoec.ca

Principal Investigator:

Naveen Arya, MD

Taunton Surgical Center

Recruiting

Oshawa, Ontario, Canada, L1J 0C7

Contacts

Alana Carter, BSN, MN

905-723-8551alanacarter01@gmail.com

Principal Investigator:

Daniel Green, MD

Toronto Immune and Digestive Health Institute

Recruiting

Toronto, Ontario, Canada, M6A3B4

Contacts

Kaitlyn Mitchell, RN, BScN, MSc

647-812-2113kmitchell@tidhi.ca

Janet Saad

647-812-2113mschwartz@tidhi.ca

Principal Investigator:

Petros Zesos, MD

The Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Pascale Germain

514-934-1934pascale.germain@muhc.mcgill.ca

Principal Investigator:

Waqqas Afif, MD

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada

Contacts

Karine Paupert

514-890-8000karine.paupert.chum@ssss.gouv.qc.ca

Principal Investigator:

Robert Battat, MD

More Information

Sponsor

TIDHI Innovation Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TIDHI Innovation Inc. on 2026-08-31.